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Home , Aphakia, Ectropion, Heterophoria, Onchocerciasis, Trachoma, Visual impairment

Prevalence of , and main avoidable causes in Chao Nan area

Department and Visual sciences

Project Vision Charitable Foundation

Chaonan RAAB protocol version 4 1 Content ORGANIZATION ...... 3 A. SPECIFIC AIMS: ...... 5 B. Background ...... 6 C. STUDY DESIGN AND POPULATION ...... 9 C1. SAMPLING FRAME ...... 9 C2. SAMPLING PROCEDURE ...... 9 C3. SAMPLE SIZE CALCULATION ...... 10 D. TIMELINE ...... 11 E. STUDY PREPARATION AND LOGISTICS ...... 12 E.1. SURVERY TEAM ...... 12 E2. ARRANGEMENT OF SURVERY LOGISTICS ...... 12 E.3. TRAINING OF SURVEY TEAM ...... 13 E.4. INTER-OBSERVER VARIATION STUDY ...... 15 F1. EXAMINATION PROTOCOL AND CODING INSTRUCTION FOR RAAB ...... 16 F2. PROFESSIONAL EXAMINATION ...... 26 F2.1 RESEARCH TEAM ...... 27 F3. Equipment list and Clinical Examination ...... 27 G.DATA PROCESSING ...... 31 G.1. DATA ENTRY ...... 31 G.2. STATISTICAL ANALYSIS...... 31 H. PARTICIPANT DISPOSITION ...... 31 H1. REFERRALS AND TREATMENT ...... 31 H2. NON-STUDY SUBJECTS ...... 32 I. HUMAN SUBJECTS...... 33 I.1 PARTICIPATION ...... 33 I.2. RISKS ...... 33 I.3. PROCEDURE TO MINIMIZE RISKS...... 34 I.4.DIRECT BENEFIT ...... 34 J.DEFINITION OF OUTCOMES ...... 34 J.1. VISUAL IMPAIRMENT, BLINDNESS AND AVOIDABLE BLINDNESS ...... 35 J.2. CATARCAT SURGICAL COVERAGE ...... 36 K APPENDIX ...... 36 K.1 RAAB RECORD FORM ...... 36 K.2. INTER-OBSERVER VARIATIONS FORM ...... 39 K.3. THE CARD OF URGENT CONTACT TOR PARTICIPATIONS ...... 40 K.4. PATIENT INFORATION SHEET ...... 41 K.5. CONSENT FORM ...... 42

Chaonan RAAB protocol version 4 2 ORGANIZATION

Name Title and Institute Principal Prof. Dennis S. C. Department of Ophthalmology & Visual Sciences, The Investigator(PI) LAM Chinese University of Hong Kong President, Project Vision Charitable Foundation

Department of Ophthalmology & Visual Sciences, The Executive PI Xiujuan ZHANG Chinese University of Hong Kong

Xiujuan ZHANG Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong Yingpeng. LIU Joint Shantou International Center Project Vision Charity Foundation Limited Hong Kong Investigators Chongren ZHENG Project Vision Charity Foundation Limited Hong Kong Emmy Y. LI Hong Kong Eye Hospital

Project manager Xiujuan ZHANG PHD student，Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

Chongren ZHENG Project Vision Charitable Foundation Yingpeng LIU Joint Shantou International Eye Center Project Vision Charitable Foundation Project Xiujuan ZHANG PHD student，Department of Ophthalmology & Visual coordinator Sciences, The Chinese University of Hong Kong Gengqin Huang Chaonan Renmin Hospital Support Officers Chongren ZHENG Project Vision Charitable Foundation Jian WANG Project Vision Charitable Foundation Ming ZHANG Joint Shantou International Eye Center Zhexiang XIE Joint Shantou International Eye Center

PHD student，Department of Ophthalmology & Investigators Xiujuan ZHANG Sciences, the Chinese University of Hong Kong

Baohua Li Zhengzhou Renmin Hospital Xianzhong CHEN Chaonan Remin Hospital Hongwei CAI Chaonan Remin Hospital

Chaonan RAAB protocol version 4 3 Statistician Yi PENG Project Vision Charitable Foundation

Jian WANG Project Vision Charitable Foundation Data Coordinator Jiaofang CHEN Project Vision Charitable Foundation

Mingguang He State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yatsen University, Guangzhou Advisory board Nanthy Congdon State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yatsen University, Guangzhou

Supporting Institutions Chao Nan People Hospital Project Vision Charitable Foundation

Chaonan Council Coordination Committee on

This protocol complies with the Declaration of Helsinki (version 2008) and ICH-GCP guidelines.

Chaonan RAAB protocol version 4 4 EXECUTIVE SUMMARY

This proposal describes a population-based study aimed at determining the prevalence of visual impairment, blindness and major causes in adults age 50 years old and above in Chaonan County of Guangdong province, where one of the Project Vision Charity Eye center was founded in 2009.

In the proposed study, we will examine 3700 Chaonan County residents aged 50 years and older, selected via a clustered, randomized sampling with probability proportional to size (PPS). The cluster will be at the village level, 50 subjects aged 50 years and older will be examined in each cluster includes , torch light, and fundus review, the major cause of blindness or visual impairment will be determined.

This study will provide a profile of blindness/visual impairment in Chaonan. we will estimate the impact of Project Vision by comparing to the prevalence in other areas of China，which will guide us to improve the program with more efficiency and higher quality. It will provide important issues for the purposes of establishing a sustainable and suitable model to eliminate the cataract blindness in China.

A. SPECIFIC AIMS:

The specific aims of the proposed study are to determine 1) Prevalence and cause of blindness, severe VI and moderate VI based on presenting visual acuity (PVA) and pinhole visual acuity 2) To evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) 3) Prevalence of and pseudophakia; 4) Cataract surgical rate and coverage

Chaonan RAAB protocol version 4 5 5) Visual outcome of 6) Barriers to cataract surgery 7) Cataract surgery service indicators (age at time of surgery, place, costs and type of surgery, cause of visual impairment after cataract surgery)

B. Background

Recently released World Health Organization (WHO) data indicate that the prevalence of visual impairment and blindness is still high. A total of 285 million are visual impaired and 39 million are blindness[1]. Cataract is by far the most common cause of visual loss, accounting for approximately half of all global blindness. China, with the largest population in the world, has the low cataract surgical rates (CSR) in , at 772 cases per 1 million population per year[2].

As evidenced by the Sight First China Action initiative established in 1997[3] and with the current government “One Million Cataract Program”, blindness (particularly from cataract) is a high priority publication health issue in China.

However, it’s seemed that the results were not encouraged A study conducted in 2006 from nine-province of China showed the prevalence of blindness and cataract surgery is 2.29% [4]and 2.09%[5] respectively. Surgical coverage among those with visual acuity worse than 20/200 in both due to cataract was only 35.7%[5]. Shortage of ophthalmologists and eye surgical services is some of the major reasons. In view of the situation, Project Vision, a Hong Kong-based non-governmental organization, was created[6] as a new and innovative model for training local surgeons in rural China.

Chaonan[7] is a rural area in Shantou City, Guangdong province ,southern

China with 1,436,416 population. Its mean income per capita is 3234￥,

Chaonan RAAB protocol version 4 6 and more than 80 percent of the population making their living on agricultural products. Chaonan County is located in east of Shantou about 2 hours drive from Shantou. Before Project Vision established in this county, cataract surgeons were not available. In 2004, the Project Vision launched in the Chaonan Town. Two local doctors were trained as independent cataract surgeons. Since then the number of patients receiving cataract surgery in

Chaonan have steadily increased from 862 in 2004 to 1539 in 2008[8]. So far till now, more than 7,000 cataract surgeries has been performed, some of whom are from neighbor town. However, it remains unknown whether there are still a large number of patients with avoidable visual impairment and blindness, especially leaded by cataract in this town. There is a need to investigate the reasons behind non-acceptance of cataract surgery and whether screening programs can promote the uptake of cataract surgery.

Rapid assessment of avoidable blindness (RAAB) has been developed and standardized as a simple and rapid survey to provide data on the prevalence and causes of blindness [9, 10]. So far, RAAB has been successfully undertaken in India[11], Kenya[12], Bangladesh[13], Rwanda[14], [15].,

i[16] [17] [18, 19] Malaw , Palestinian , and China . We plan to follow the RAAB protocol to examine 3700 residents randomly selected from Chaonan County. In addition, the purpose of the current study is to evaluate the diagnostic accuracy of RAAB for detection of the prevalence and causes of blindness in a population aged 50 years and older.

1. www.vision2020.org. 2. http://www.gov.cn/gzdt/2010-05/10/content_1603094.htm. 3. Sight first China action helps 2.6 million cataract patients.China Daily. October 15, 2003: Lifestyle News. Available at: http://www.chinadaily.com.cn/en/doc/2003-10/15/content_272325.htm. Accessed February 26, 2009. 4. Zhao JL, E.L., Cui H, et al., Prevalence of Vision Impairment in Older Adults in Rural China. The China Nine-Province Survey. Ophthalmology, 2010. 117: p. 409–416.

Chaonan RAAB protocol version 4 7 5. Zhao JL, E.L., Cui H, et,al. , Prevalence and Outcomes of Cataract Surgery in Rural China. The China Nine-Province Survey. Ophthalmology, 2010. 117: p. 2120–2128. 6. Lam DS, C.N., Rao SK, et al. , Visual outcomes and after sutureless, manual cataract extraction in rural china: Study of Cataract Outcomes and Up-Take of Services (SCOUTS) in the Caring Is Hip Project, Report 1. . Arch Ophthalmol. , 2007;. 125:: p. 1539-1544. 7. http://www.raoping.gov.cn/rpgk/index.asp#. 8. Lam DS, E.L., David Chang et al., Project vision: a new and sustainable model for eliminating cataract blindness in China. Clinical and Experimental Ophthalmology, 2009. 37: p. 427–430. 9. Dineen B, F.A., Faal H. , A rapid methodology to assess the prevalence and causes of blindness and visual impairment. Ophthalmic Epidemiol 2006;. 13: : p. 1-4. 10. Resnikoff S, P.D., Etya’ale D, et al. , Global data on visual impairment in the year 2002. . Bull World Health Org 2004;. 82:: p. 844 –851. 11. John Neena, J.R., Vashist Praveen, Gudlavalleti V. S. Murthy, Rapid Assessment of Avoidable Blindness in India. PLoS ONE, 2008,August 3(8): p. e2687. 12. Mathenge W, K.H., Limburg H, Polack S et al. , Rapid Assessment of Avoidable Blindness in Nakuru District, Kenya. . Ophthalmology. 114: p. 599-605. 13. Wadud Z, K.H., Polack S, Lindfield R, Akm MR, Choudhury KA et al. , Rapid Assessment of Avoidable Blindness and Needs Assessment of Cataract Surgical Services in Satkhira District, Bangladesh. . Br J Ophthalmol 2006 Oct. 90(10): p. 1225-1229. 14. Mathenga W, N.J., Limburg H, Kuper H Rapid assessment of avoidable blindness in Western Rwanda: blindness in a post conflict setting. PLoS Med . 2007. 4: p. e217. 15. Habiyakire C, K.G., Courtright P, Lewallen S, Rapid assessment of avoidable blindness and cataract surgical services in kilimanjaro region,Tanzania. . Ophthalmic Epidemiol 2010(17): p. 90–94. 16. Khumbo Kalua, R.L., Maxwell Mtupanyama, Davie Mtumodzi, Vincent Msiska, Findings from a Rapid Assessment of Avoidable Blindness (RAAB) in Southern Malawi. PLoS ONE 2011. 6(4): p. e19226. 17. Far Chiang, H.K., Robert Lindfield, Tiarnan Keenan et al., Rapid Assessment of Avoidable Blindness in the Occupied Palestinian Territories. PLoSONE 2010. 5(7): p. e11854. 18. Min Wu, J.L.Y.Y., Hannah Kuper, Rapid Assessment of Avoidable Blindness in Kunming, China. Ophthalmology 2008. 115: p. 969–974. 19. Baixiang Xiao, H.K., Chunhong Guan,Kirsten Bailey,Hans Limburg, Rapid assessment of avoidable blindness in three counties, Jiangxi Province, China. Br J Ophthalmol 2010. 94: p. 14371442.

Chaonan RAAB protocol version 4 8 C. STUDY DESIGN AND POPULATION

C1. SAMPLING FRAME

In Chaonan County, there are about 244 villages, with a mean size for each village of 5887 residents. Assuming 10% of subjects will not respond, we need to enroll 3700 subjects. Because of logistical and time constraints, the number of clusters in which conventional assessment was conducted therefore was reduced by replacing 60% of the clusters from the originally sampled list of clusters with a standard RAAB. Based on the recommendation on sample size estimation for screening tests with a low pretest probability in a diagnostic accuracy study, 1,000 or more participants were often required to adequately evaluate an index test.12, 13 The proposed number of participants in our study was 2250, which was fully achieved in this subsample. All the 74 villages’ names were written on small pieces of paper and 45 were randomly picked. As a pre-planned process, a random sample of 60% of the enrolled subjects (2250) were then re-examined by means of a conventional ophthalmic examination in a mobile eye clinic equipped with standard ophthalmic instruments set up in a village center. C2. SAMPLING PROCEDURE

We used a landform-stratified, clustered, randomized sampling with probability proportional to size (PPS).

Selection of clusters from sampling frame 1. Sampling frame is list of all population units in the survey area with indication their population size 2. A cumulative column of population is constructed

3. This cumulative list represents all ‘persons’ in survey area and in each geographical sub-area 4. The total population is divided by the required number of clusters to

Raoping Eye study protocol version 5 calculate sampling interval 5. The starting point is determined by multiplying sampling interval by a random number between 0 and 1

6. Add sampling interval to starting point to identify second ‘person’ and so on.

7. A list of the population units is made where the selected ‘persons’ are living. These are the locations of the clusters. 8. This procedure ensures random selection of clusters with a probability proportional to the population size

Compact segment sampling

1. If the area from which the cluster has to be selected has a large population, the population unit is divided into equal segments with each having enough population to provide required number of eligible subjects (aged 50+). One segment from each selected population unit is chosen by simple random sampling and all eligible subjects in this segment are to be included to form a cluster. 2. If the area from which the cluster has to be selected has a small population, the eligible subjects (aged 50+) are less than the population unit, the rest subjects were replenished from the nearest village. 3. Population in segment:

Cluster size / % population 50+ (e.g. 50 / 27 % = 185)

C3. SAMPLE SIZE CALCULATION

1) Expected prevalence is P. Assuming P is 2.68%, which[4] is estimated

prevalence of blindness in people ≥ 50 years in Guangdong Province from nine province of Mainland China was in 2010 and should be able to cover most of the common eye .

2) Relative precision is 25% and the absolute precision (d) is 2.68% x 0.2 = 0.54%.

Raoping Eye study protocol version 5 3) Reliabitiy 1-α, Set it as 95%，z1-α/2=1.96

4) deff（design effect）is set to 1.5

Then the number of sample

Given a population size of in Chaonan county with 27.58% of them aged 50 or above, yielding a target population of the minimum sample size required is. Assume a 90% response rate, the planned sample size is 3700

D. TIMELINE

2013 Mar. Apr May. May June July Aug. Sep. Phases 15- 23- 1-- 11- 1-- 15- 1-15 -22 31 10 30 15 22 22-30 1 31 Phase + To get the sample frame Ⅰ： +

Protocol completion +

Submission Protocol, CREC + +

Instrument preparation + + +

Sampling completion +

Survey area submission +

Staff arrangement completion +

Phase Staff training + Ⅱ Pilot study +

RAAB implementation + + + +

Phase Analysis & publication + + + + + Ⅲ

Raoping Eye study protocol version 5

E. STUDY PREPARATION AND LOGISTICS

E.1. SURVERY TEAM

Each team consists of 6 peoples, their responsibilities are: 1) One ophthalmologist is to undertake eye examinations and to determine the cause of visual impairment (team leader) is responsible for the quality control of the field work. 2) One person to undertake visual acuity examinations, another person would assist to do the examination and assist to complete the questionnaire. 3) Two community workers or village leaders from the study village/clustwill join to guide the team and communicate with the local people. 4) The driver might be possible to be trained to assist visual acuity examination)

E2. ARRANGEMENT OF SURVERY LOGISTICS

1) Arrangement of survey equipment and transport

Equipment List

 A pencil + eraser + sharpener for each team member  Clipboard to keep the Survey Records and to facilitate data recording.  Simplified vision-testing card. The card can be made from strong white cardboard, of a size of 15 x 15 cm (6 x 6 inch). On one side it should have

one optotype “E” of size 60, on the other side one optotype conform to size 18. Alternatively, the optotype “E” could be replaced by optotype “C”

Raoping Eye study protocol version 5 of similar sizes. Each team should have at least 3 cards in case any is lost or damaged

 One tape or rope of 6 metres (20 feet) with a knot or ring in the middle at 3 metres (10 feet)

 Occluder with pinhole, preferably with multiple holes  Portable slit lamp with short-acting mydriatic  Torch with focused light and spare batteries  Direct ophthalmoscope with spare batteries  Blood taking sets  Shoulder bag to carry all materials;  Identity card;

2) Arrangement of survey schedule (date and team for each cluster)

E.3. TRAINING OF SURVEY TEAM

Standard Training Program for Survey Team

1) Day 1: survey design and planning, selection of clusters Participants: organizers, survey coordinator, data entry clerks, team leaders of survey teams Morning

 background and principles of RAAB  quick overview of survey methodology  principles of the software package Afternoon

 calculation of sample size  proposal of sample design  selection of clusters

Raoping Eye study protocol version 5  selection of cluster for field practice (inform local leaders)  planning for inter-observer variation assessment

2) Day 2: training of field staff Participants: survey coordinator, data entry clerks, all members of survey teams Morning

 how to complete the survey form  protocol for examination of subjects  exercise: visual acuity screening and examination Afternoon

 how to conduct the survey in the villages  preparations for inter-observer variation assessment  installation of RAAB software and training of data entry clerk  instructions on the use of the RAAB software (data entry clerk)

3) Day 3: training of field staff, inter-observer variation Participants: survey coordinator, data entry clerks, all members of survey teams Morning

 inter-observer variation assessment  data entry of inter-observer variation records Afternoon

 analysis of results  discussion of findings with all the teams  how to conduct the survey in the villages  informed consent

4) Day 4: field practice Participants: survey coordinator, all members of survey teams

Raoping Eye study protocol version 5 Morning

 practical exercise in one of the selected clusters. If all goes well then this becomes the first completed cluster. Afternoon

 after field exercise the entire group meets again for 1-2 hours to discuss experiences from the survey work

 data entry of survey records (data entry clerks) Page 53 of 183  create consistency report  practical exercise on use of RAAB software (consistency checks, creation of reports)

E.4. INTER-OBSERVER VARIATION STUDY

Procedure 1) Select a group of 40-50 people from Chaonan County Hospital, all aged 50 years and above.

2) Each person will be given an identification number written on a piece of paper, which must be shown to each examiner.(how many examiners)

3) Each person is examined by each team, in turn. Each team fills in an Inter-Observer Variation Test form (see below) with the number of the team and the individual's identification number and then proceeds to the visual acuity assessment, pinhole examination, examination and the assessment of the main cause of a presenting vision <6/18.

4) The person then moves on to the next team. There need not be a consistent order in which the people are examined by each team. The teams should not share their findings with the other examiners.

Raoping Eye study protocol version 5

5) At the end of this exercise, each team will have a pile of forms, equal to the number of persons examined. Each team has to check all forms for completeness and whether all patients have been seen by all examiners.

6) All forms are then entered into the RAAB software package by the data entry clerk.

8) Interobserver agreement (IOV) is expressed in the Kappa coefficient. A Kappa of 1.00 indicates perfect agreement between examiners; A Kappa of 0 indicates no agreement other than what can be attributed to chance. Any team scoring a Kappa of less than 0.60 should be retrained before it is allowed to participate in the fieldwork. (we need to do this with RAAB software)

F1. EXAMINATION PROTOCOL AND CODING INSTRUCTION

FOR RAAB

Section A: General Information

Method: 1) For each eligible person, a RAAB Survey Record has to be completed, whether the person is examined, is absent, refused examination or was unable to communicate (e.g. deaf, dementia or psychiatric illness). 2) In each household all persons of 50 years and older, residing in the household for six months or more over the past year, are examined and interviewed.

3) “Residing in the household” is defined as “sharing meals from the same kitchen with the other members of the household for at least 6 months in a year.

Raoping Eye study protocol version 5 Exclude any visitors. 4) Always check whether there are any other eligible people residing in the household that are not present at the time of visit. If so, complete a RAAB survey record for them and arrange to revisit at an appropriate time. 5) Do NOT complete a record for any person above 50 years who is a guest or a visitor from another house or area, although the team may check their eyes as a courtesy.

Coding:

Section A: General Information

Item Instructions

Year Enter year of examination. Also write this on the cover page.

Month Enter month of examination. Also write this on the cover page.

Survey area A defined geographical or administrative area, such as a district, a group of districts, a province, or an entire country, from where the clusters are selected. Write the name and a two-digit ID code number. Survey area code Write a one or two-digit code number. In the case of stratified sampling, use a different area code for each stratum. Cluster No. Write the number of the cluster as it appears in the list of the sample design. Write name and number of the cluster area also on the cover page. Individual No. Sequential number of eligible persons in a cluster.

Name Person name, to be written in local language, as appropriate. This item will not be included in the data processing, but may be useful to trace people for follow up (if needed). Sex Mark the appropriate circle: male (1) or female (2).

Age Record age in years; estimated, if no official certificate available. For ages of 50 to 98, use the age in years; for ages of 99 or higher, write 99. The software will not accept any age below 50. Optional 1 and 2 These fields may be used for collection of additional information, such as ethnic group, occupation, literacy, insurance cover, etc. Survey staff should be provided with appropriate codes for these items. There is no automatic analysis for these two fields. When these options are used the original data file can be sub-divided on the basis of the optional codes and each of the new files can be analysed independently to compare results. Examination Status Mark

 ‘Examined’ (1) when a subject can be examined.

Raoping Eye study protocol version 5  ‘Absent’ if a resident is not present during the survey period, even after repeated visits.

 ‘Refused’ (3) when a resident refuses to be examined.

 ‘Unable to communicate’ (4) when a resident is profoundly deaf, has dementia or psychiatric illness so that it is not possible to test their visual acuity.

Section B: Vision

Method:

1) Visual acuity is measured with a chart with an “E” optotype of size 18 of the Snellen chart on one side and an “E” optotype of size 60 on the other side at 6 or 3 metres distance with available correction. 2) This is best done in full daylight, in the courtyard or on the street. 3) Distance is measured with a special tape of 6-metre length, with a ring/knot at both ends and one in the middle (3 meters). The examiner puts one ring around a finger and keeps that hand against the chest; the examinee does the same with the ring at the other end of the tape. 4) First the right eye is examined, while the left eye is covered with the palm of a hand or an occluder, either by the examinee, or by a helper. 5) The examinee should stand in the shade or with his or her back to the sun, while the E chart is kept up in clear daylight. 6) Vision is tested separately for each eye.

7) First the ‘E’ chart is shown from nearby, the procedure is explained and the examinee is instructed to point in the direction of the open ends of the “E”. Then the “E” optotype of size 6/60 is shown first at a distance of 6 metres. It is advisable to start with the larger E to test if the patient understands the procedure. 8) If they can see the E size 60 at 6 metres (6/60), change to the E size 18 at 6 metres distance (6/18). If they cannot see the E size 60 at 6 metres, change to size 60 at 3 metres (3/60).

9) If the “E” of size 60 cannot be seen at 1 metre distance, check with a torch

Raoping Eye study protocol version 5 in semi-dark condition (inside the house) whether the person has of light (PL+) or not (PL-). 10) The optotype is rotated before each reading to change the direction of the open ends. This rotation should be in varying directions to avoid memorising. 11) The criteria for vision at a certain level are 4 correct consecutive showings, or 4 correct out of 5 showings. 12) An eye with a presenting VA better than 6/18 does not need to be examined with pinhole. Just mark code 1 for pinhole vision. 13) Any eye with a presenting VA less than 6/18 has to be examined for acuity with a pinhole as well. 14) If the person wears spectacles, place the pinhole in front of the spectacles. Page 60 of 183

Coding:

Section B: Vision

Item Instructions

Glasses Mark the appropriate circle for distance only. If the person wears glasses for distant vision these should also be used during the vision testing. Presenting vision in right Mark the appropriate circle for each eye. Only one entry is allowed. and left eye

Pinhole vision in right and If presenting vision is 6/18 or better, then pinhole vision is the same. All eyes with left eye VA<6/18 should be also tested with pinhole. If vision was tested with glasses, these should be used here as well. Place the pinhole in front of the patient’s glasses.

The classification of visual impairment used in this package is in accordance with the International Classification of Diseases (ICD-10), 1992:

 Visual acuity of 6/18 or better is considered as normal vision

 “Visual impairment” refers to visual acuity less than 6/18 but at least 6/60.

Raoping Eye study protocol version 5  “Severe visual impairment” refers to visual acuity less than 6/60 but at least 3/60.

 "Low Vision" refers visual acuity less than 6/18 but at better or equal to 3/60.

 "Blind" refers to visual acuity less than 3/60.

Definitions of Visual Loss in this package:

Visual impairment VA< 6/18 – 6/60 in better eye with best correction or pinhole Severe visual impairment VA< 6/60 – 3/60 in better eye with best correction or pinhole Blindness VA< 3/60 in better eye with best correction or pinhole  Conditions of the visual field are not taken in consideration in this survey

Section C: Lens Examination

Method: The examinee is taken inside the house, where you find or create a shaded or dark area. There, the lens status is assessed by torch and by distant direct ophthalmoscopy at 20-30 cm distance in semi-dark condition, without dilatation of the . Examine the lens in each eye and mark your observations in Section C: normal lens or minimal lens opacity; obvious lens opacity present, lens absent (aphakia), IOL implanted without posterior capsule opacification or IOL implanted and posterior capsule opacification present. If you cannot see the lens because of corneal scarring, or other causes, mark “No view of lens”

Coding:

Section C: Lens Examination

Item Instructions

Normal lens, Crystal clear lens or minimal lens opacity, unlikely to cause reduction of visual minimal lens opacity acuity. Clear or minimal dark shading of the red reflex.

Raoping Eye study protocol version 5 Obvious lens opacity A pupil that clearly appears grey or white when examined with oblique light in a shaded or darkened area. With distant direct ophthalmoscopy an obvious dark shading of the red reflex is visible. Note: This item refers to a major opacification of the lens, leading to low vision or blindness. Section F has to be filled in when there is an obvious lens opacity and a pinhole VA <6/18 in one or both eyes. Lens absent (aphakia) Absence of lens from the central pupil. May be judged to be present when there is a reliable history of cataract extraction and/or if other evidence of absence of the lens from the central pupillary area, such as tremulousness. A completely dislocated lens, as occurs with or trauma, should also be recorded as aphakia. Lens absent (aphakia) Absence of lens from the central pupil. May be judged to be present when there is a reliable history of cataract extraction and/or if other evidence of absence of the lens from the central pupillary area, such as iris tremulousness. A completely dislocated lens, as occurs with couching or trauma, should also be recorded as aphakia. Pseudophakia without PCO As aphakia, but with Intra-Ocular Lens (IOL) inserted. No Posterior Capsule Opacification (PCO) to be seen with the unaided eye. Pseudophakia with PCO As aphakia, but with Intra-Ocular Lens (IOL) inserted. Obvious Posterior Capsule Opacification (PCO) to be seen with the unaided eye. No view of lens Mark if the lens cannot be seen because of dense , Phthisis, or for other reasons.

Section D: main and principal cause of presenting vision less than 6/18

Method:

1) Examination is done with handheld slit lamp together with direct ophthalmoscope.

2) If the VA was 6/18 or better in the eye then mark ‘not examined – can see 6/18’ 3) Mark the principal disorder responsible for visual loss in each eye as well as in the individual (better eye) after considering disorders in either eye, which are most amenable to treatment or prevention. 4) When there are two disorders, one of which is secondary to the other, the primary is to be selected as the principal disorder. For example, if the patient has cataract secondary to , glaucoma is the principal disorder.

Raoping Eye study protocol version 5 5) When there are co-existing primary disorders in the same or different eyes, mark as the principal disorder that which is most readily curable or preventable. 6) The following is a recommended ranking of the disorders with respect to these criteria: 1. 2. Cataract 3. Uncorrected aphakia 4. Surgery related complications 5. Preventable corneal opacities and phthisis 6. (Primary) glaucoma 7. Other posterior segment disorders.

Coding:

Section D: Principal Cause of Vision <6/18 with available correction

Item Instructions Refractive error Phakic eyes with VA< 6/18, improving with pinhole or optical correction to 6/18 or better. Cataract, untreated Obvious lens opacity, obscuring a clear red reflex, which is likely to affect vision. Do not mark this option in cases of minor opacities, unlikely to affect vision. Aphakia, uncorrected Aphakia (absence of lens from the central pupil), improving with correction or pinhole to 6/60 or better. For aphakia where VA does not improve with proper correction, other causes of visual loss should be determined and recorded appropriately, while uncorrected aphakia should not be marked. If there is clear evidence that a surgical procedure has led to a blinding condition, e.g. secondary glaucoma, then “surgical ” should be marked as an underlying cause. Surgical complications If there is evidence that a surgical procedure has led to a blinding condition, e.g., secondary glaucoma, then this box should be marked. Uncorrected aphakia must be recorded as above.

Raoping Eye study protocol version 5 Central corneal scarring in the presence of at least one of the following signs of trachoma:

/ ;

 conjunctival scarring;

 pannus, or;

 Herbert’s pits.

Phthisis Small shrunken due to trauma or severe . Other corneal scar Leucoma, staphyloma, or other easily visible corneal opacity present over the pupil (no signs of trachoma). Globe abnormality Microphthalmos, anophthalmos, enucleated eye. Glaucoma Mark if any of the following suggested criteria apply:

 the eye is stone hard on digital palpation;

 an afferent pupil defect and corneal oedema;

 the vertical cup-disk ratio is 0.8 or greater.

This is not a complete diagnosis for glaucoma, but only used for the purpose of this survey, since tonometry and testing of visual fields is not practical under field conditions and glaucoma is not the focus of this survey. Diabetic This diagnosis applies only for persons with confirmed . The shows either:

 proliferative retinopathy (growth of new blood vessels with or without haemorrhages), or;

 diabetic macular oedema (extensive swelling of the central retina).

Age-Related Macular ARMD refers to obvious or severe pigment disturbances at the macula from what is Degeneration (ARMD) considered “normal” in the absence of other known causes. Check if any of the following suggested criteria apply:

 the pigment epithelium is disturbed by atrophy, or proliferation (mottling);

 drusen (yellow colloid-like dots);

 swelling or oedema of the central retina;

 circinate exudates;

 Haemorrhage;

 Macula hole.

Raoping Eye study protocol version 5 In the presence of dermatological signs of onchocerciasis there is either:

 sclerosing ;

 chronic iridocyclitis;

 chorioretinal atrophy; or,

 optic atrophy.

Other posterior segment or If the VA<6/18 cannot be attributed to any of the above mentioned causes, but a CNS disorder: specific cause can be identified then use this diagnosis. Not examined Mark if the patient has vision of 6/18 or better in this eye and there was no indication to examine.

Section E: History, if not Examined

Method:

Whenever an eligible person in the cluster is found absent, refuses to be examined, even after repeated visits or is unable to communicate (profound deaf, dementia or psychiatric )

(status=2, status=3 or status=4), section E has to be completed.

Coding:

Section E: History, if not Examined Item Instructions Believed not blind Vision in either eye allows subject to move around freely and to participate in social life. Believed blind due to Visual impairment limits social interaction. Use the local name for cataract to assess cataract whether blindness is attributed to cataract. Believed blind due to other Visual impairment limits social interaction. Blindness is not attributed to cataract causes (use local name). Believed operated for Visual impairment inhibited social interaction in the past. Subject was operated, cataract reportedly for cataract.

Section F: Why cataract operation has not been done

Raoping Eye study protocol version 5

Method: 1) Ask people with obvious lens opacity and visual impairment or blindness

(VA<6/18 in one or both eyes with pinhole) the standard question: “Why have you not been operated for cataract?” 2) Match the answer of the patient with the barriers mentioned in the list and the answer closest to the patient’s answer should be marked. 3) Mark at least one and a maximum of two barriers.

Coding:

Section F: Why cataract operation was not done 1 Unaware that treatment is possible 2 Believes it to be destiny / God's Will 3 Told to wait for cataract to mature 4 Surgical services not available or very far 5 Don't know how to get surgery 6 Cannot afford operation 7 No one to accompany 8 No time available / other priorities 9 Old age and need not felt 10 One eye adequate vision / need not felt 11 Fear of operation 12 Fear of loosing eye sight 13 Other disease contra-indicating operation

Section G: Details about cataract operation

Method: 1) This section is only filled in for people who have undergone cataract surgery. 2) Ask operated patients about their age at the time of cataract surgery. 3) Ask them where the operation was conducted: in a government, charitable or private hospital, in an ‘eye camp’ (surgery performed by qualified ophthalmic staff in an improvised operation theatre) or in a ‘traditional setting’ (surgery

Raoping Eye study protocol version 5 performed at home or in the premises of a traditional healer or ‘coucher’). 4) Mark ‘Non IOL’ if the patient did not get an IOL implanted at the time of surgery. Mark ‘IOL ’ for PC-IOL and for AC-IOL, also when these IOL’s are dislocated. Mark ‘Couching’ if there is evidence of dislocation of the lens and iris tremulousness, or if couching is ascertained during interview. 5) Ask operated patients whether they paid anything for the cost of surgery, whether the operation was free, partially free or paid. Costs on transportation, food or should not be counted. 6) If the VA is less than 6/18 after cataract surgery, try to assess the cause of poor VA. If the patient did not regain full sight after an uncomplicated surgery because another eye disorder in the same eye caused loss of vision as well, then mark ‘Ocular comorbidity’. If the poor outcome is due to complications during cataract surgery, mark ‘Operative complications’. If the vision after cataract surgery can be improved with pinhole, then mark ‘Refractive error’. Uncorrected aphakia should also be marked as refractive error for this question. Finally, in case of initial good outcome and subsequent vision loss due to postoperative capsule opacification or , mark ‘Long term complications’. If the VA is 6/18 or better, or if the loss of vision after surgery is caused by another condition than cataract surgery, mark ‘Not applicable, can see 6/18’. 7) Finally, ask patients whether they are satisfied with the results of cataract.

F2. Conventional EXAMINATION

We randomly selected 60% of clusters (45 clusters, 2250 participants) for the

“conventional examination”

Raoping Eye study protocol version 5 F2.1 RESEARCH TEAM

Each team consists of 5 peoples, their responsibilities are: 1) One ophthalmologist is to undertake eye examinations using slit lamp and to determine the cause of visual impairment (team leader) is responsible for the quality control of the field work.

2) One eye doctor/ optometrist to undertake refractive examination and visual acuity examinations, another person would assist to do the examination. 3) One person was trained to complete the questionnaire. 4) Two community workers or village leaders from the study village/clustwill join to guide the team and communicate with the local people.

F3. Equipment list and Clinical Examination

1) Slit lamp 2) Auto

F3.1. Autorefraction

The refraction (sphere, cylinder and axis) and corneal curvature will be measured using an autorefractor machine (Auto Refractometer KR 8800, TOPCON CORP ,Janpan) operated by optometrists or trained technicians (see AppendixA).

F3.2. Visual Acuity

Presenting visual acuity will be measured binocularly, and then monocularly

(right eye followed by left eye) with the participant’s existing refractive correction (spectacles or contact lenses), if any. VA (VA wearing present corrective device or without, if currently not wearing any) will be measured

Raoping Eye study protocol version 5 using Logarithimci Viual Acuity Chart (Precision VisionR,USA)at a distance of 4 meters. On each monocular measurement, the contralateral eye is occluded with eyepatch. With poor acuities the chart distance can be reduced to 1 meter allowing acuities as low as 1/40 (0.025) to be measured.

F3.3 Subjective Refraction

Subjective refraction will be performed on all subjects with vision of 0.5 or worse( less than 20/32) in either eye using a trial frame placed and adjusted on the participant’s face. Autorefraction readings will be used as the starting point and refinement of sphere, cylinder and cylinder axis will be performed until the best VA is obtained by experienced optometrist.

F3.4 Slit Lamp Biomicroscopy

Slit lamp biomicroscopy will be performed and any abnormalities, specifically including corneal opacities (including ), corneal pathology, iris new vessels, pterygia and will be noted. will be defined as a radially oriented fibrovascular lesion crossing the nasal or temporal limbus. The grading will be based on the visibility of the underlying episcleral blood vessels on slit-lamp examination. This has been previously described and validated as a marker of severity. The presence of pinguecula will also be recorded. Other slit lamp abnormalities as listed below will be recorded on a listed diagnosis sheet. , Lacrimal, : , , entropion and trichiasis, , , , proptosis, other disorders. Lid position will be determined by the position of the openings of the Meibomian Glands. Entropion: Meibomian Glands are pointing inwards Ectropion: Ectropion is defined as an outward rotation of the margin. Meibomian Glands are pointing outwards

Raoping Eye study protocol version 5 Ptosis: Ptosis is present when the upper eyelid is less than 2 mm from midpupil. Asymmetric ptosis is present in the lower of the two upper eyelids when there is 2 mm or more asymmetry between the levels of the upper eyelids, even if both eyelids are 2 mm or more from midpupil. Although ptosis is best defined in terms of the midpupil to upper lid distance, the diagnosis of ptosis rests with the examining physician based on the clinical evaluation of the patient. , External Eye: , conjunctival degenerations, deposits or scarring, , , other disorders. Corneal Disease: , superficial keratin's, , interstitial or deep keratitis, corneal neovascularisation, herpetic keratitis, corneal scars or opacities, corneal oedema, bullous keratopathy, corneal degenerations, hereditary corneal dystrophies, , other disorders. The limbal anterior chamber depth (LACD) will be recorded as a percentage fraction according to the modified van Herick grading system. The grading of limbal chamber depth will be carried out at a slit lamp. The illumination column was offset from the axis of the microscope by 60°. The brightest, narrowest possible vertical beam of light will be directed at the temporal limbus, with the beam of light perpendicular to the ocular surface, and viewed from the nasal aspect. The beam will be positioned at the most peripheral point of the that would allow a clear view of the anterior chamber and peripheral iris. The objective magnification will be set to ×1.6, giving ×16 magnification overall. The LCD was then graded as a percentage fraction of the thickness of the adjacent cornea in the following seven categories: 0%, 5%, 15%, 25%, 40%, 75%, and 100%. LACD < or=25% is a indication for gonioscopy. Disorders of Globe: hypotony, blind hypotensive eye (phthisis bulbi), blind hypertensive eye (absolute glaucoma), other disorders

Iris and : anterior , heterochromia including Fuch’s, , degenerations or cysts of iris or ciliary body, essential iris atrophy, pupil abnormalities, other disorders.

Raoping Eye study protocol version 5 : Only tropias will be recorded as either present or absent. They will be listed as: , , intermittent strabismus, , paralytic strabismus, mechanical strabismus, Brown’s syndrome, Duane's syndrome, progressive ext ophthalmoplegia, , other disorders. Ocular surface examination including BUT examination Grading Ocular Surface Staining 56 Clinical grading will record whether each eye is phakic, aphakic or pseudophakic (posterior chamber, anterior chamber or iris clip ), or enucleated.

F3.5 Intraocular pressure examination

Non invasive intraocular pressure examination such as I-care or non-contact tonometer wil be performed if the participants are glaucoma suspect

F 3.6 Fundus and Examination

The fundus and optic disc will be examined with using slitlamp biomicroscopy through a 78D lens at 16 magnification or direct fundus microscopy or a fundus photography

Raoping Eye study protocol version 5

G.DATA PROCESSING

G.1. DATA ENTRY

The data of exam will be filled in paper sheets and entered onto database on a daily basis i.e. on the same day or the next day by two independent typists. The data coordinator will supervise all data entry. Internal consistency checks will be incorporated in the database system. When the protocol is finalized, based on the form of investigation and questionnaire, database should be designed with epidata. A pilot study to test the database will be done before field works start. The form is required to be convenient for data entry.

G.2. STATISTICAL ANALYSIS

Statistical analyses will be conducted using standard statistical software (SAS, SPSS). Prevalence estimates for all outcomes (visual impairment, blindness etc) will be performed for the overall sample, and then in age- and gender-stratified groups. Differences in prevalence between gender and age-groups will be analyzed using chi-square test. Standardized prevalence will be analyzed to estimate the overall burden of eye diseases.

H. PARTICIPANT DISPOSITION

H1. REFERRALS AND TREATMENT

Participants needing further examination or therapy will be referred to the Joint

Shantou International Eye Center (JSIEC) to the severity of the disease. This

Raoping Eye study protocol version 5 will occur: At the end of the examination, an ophthalmologist will review the findings to refer urgent cases. These include, but are not limited to, the followings: glaucoma (raised IOP, increased CDR), advanced cataract, proliferative and pre-proliferative , advanced age-related , retinal tears and detachment and other retinal conditions

 Non-emergencies cases 1) Cases with eye problems can be referred to the Joint Shantou International Eye Center (JSIEC) 2) For other medical problems, they can approach any local hospital or private hospital 3) A memo card will be given to the patient which they can use when consulting the relevant medical help

 Emergencies A protocol for dealing with emergencies will be established in the Joint Shantou International Eye Center (JSIEC). The principles are as following: 1) Cases requiring urgent eye care will be sent to the Joint Shantou International Eye Center (JSIEC) 2) Non-eye problems can be referred to the emergency departments in county hospitals or city hospital

H2. NON-STUDY SUBJECTS

As part of our strategy to increase recruitment, public announcements, including feature segments in local television will be made. Despite best efforts to make clear that the study’s participants were pre-selected through our sampling strategy and no exception can be made for non-selected persons to

Raoping Eye study protocol version 5 become eligible study participants, we expect that a small number of people may still be interested to come in for the eye screening as featured in the media.

Many may just not know of the proper avenue for help. In impromptu cases who are confirmed to be ineligible as study participants want to have eye examinations , they will be given a simple and complimentary eye check-up. Strictly no data will be captured and used for research purposes.

I. HUMAN SUBJECTS

I.1 PARTICIPATION

The study will be described, and they will be asked to participate.During the examination phase of the study, persons will be contacted by door to door visit

The participant will be told about the objectives, benefits and risks. Once the research team is assured that the participant understands the study, the participant will be asked to sign the consent form. The consent form will be retained by the study team.

I.2. RISKS

The risks involved in the examination are low. All tests are non-invasive, such as visual acuity test, torch light examination and direct ophthalmoscopy with undilated pupil. The investigation will do no harm to the participants.

Raoping Eye study protocol version 5 I.3. PROCEDURE TO MINIMIZE RISKS

Data to be published will deal only with groups of participants and no participant will be identified by name. Demographic information is separated from medical information on the computer. Participants have a 6 digit identification number and a two to four letter name code.

I.4.DIRECT BENEFIT

A brief explanation of age-related ocular diseases will be given to each participant. Those persons with severe diseases, for example diabetic retinopathy for which photocoagulation treatment may be indicated and who are not aware of this situation may benefit from being made aware of the need for ophthalmic consultation and possible treatment. Patients with elevated intraocular pressure or cup/disc asymmetry will learn that periodic careful ocular examination is desirable to detect the development of glaucoma. Participants will continue to receive information about results of the whole study and will obtain free eye check-up.

Society in general will benefit from insights gained from the study. 1) Data on prevalence of visual impairment, blindness and major eye diseases in Chaonan County will guide the planning of eye care services in rural area in China. 2) Optimal methods of population screening for major eye diseases will be developed from knowledge obtained from this study

J.DEFINITION OF OUTCOMES

Raoping Eye study protocol version 5 J.1. VISUAL IMPAIRMENT, BLINDNESS AND AVOIDABLE

BLINDNESS

WHO definition

Blindness is definded as best-corrected visual acuity(VA) <0.05，or a visual field <10 degrees around central fixation, in the better eye

Low vision is definded as 0.3> best-corrected VA>=0.05， or a visual field <20 degrees around central fixation) in the better eye. In this study, visual field will be not considered for blindness and low vision defining.

The classification of visual impairment used in thisstudy is in accordance with the International Classification of Diseases (ICD-10), 1992:

 Visual acuity of 6/18 or better is considered as normal vision  “Visual impairment” refers to visual acuity less than 6/18 but at least 6/60.

 “Severe visual impairment” refers to visual acuity less than 6/60 but at least 3/60.

 "Low Vision" refers visual acuity less than 6/18 but at better or equal to 3/60.

 "Blind" refers to visual acuity less than 3/60.  Definitions of Visual Loss in this package: Visual impairment VA< 6/18 – 6/60 in better eye with best correction or pinhole Severe visual VA< 6/60 – 3/60 in better eye with best correction or impairment pinhole Blindness VA< 3/60 in better eye with best correction or pinhole

Avoidable blindness refers to those that can either be treated (refractive error, cataract and uncorrected aphakia) or prevented (trachoma, corneal scarring, and to a certain extent glaucoma and diabetic retinopathy).

Raoping Eye study protocol version 5

REFERENCES 1. Nucci C, Cedrone C, Culasso F, et al .Incidence of visual loss in the Ponza Eye Study, Italy. Eye 2005 Feb;19(2):175-82. 2. Buch H, Vinding T, Nielsen NV. Prevalence and causes of visual impairment according to World Health Organization and criteria in an aged, urban Scandinavian population: the Copenhagen City Eye Study. Ophthalmology. 2001 Dec;108(12):2347-57

J.2. CATARCAT SURGICAL COVERAGE

Cataract Surgical Coverage Eyes (%) = a / (a+b) x 100 where: a = all (pseudo)aphakic eyes b = all eyes with operable cataract (PINVA<3/60, <6/60 or <6/18) It measures the proportions of eyes, blind or visually impaired due to cataract, which have been operated so far in the survey area

Cataract Surgical Coverage Persons (%) =(x+y) / (x + y + z) x 100 where x = persons with one operated and one visually impaired eye y = persons with bilateral (pseudo)aphakia z = persons bilaterally visually impaired by cataract (Presenting VA<6/18) It measures the proportion of people, blind or visually impaired due to cataract, which have been operated in one or both eyes in the survey area.

K APPENDIX

K.1 RAAB RECORD FORM

Raoping Eye study protocol version 5

Raoping Eye study protocol version 5 RAAB RECORD FORM （CHINESE）

Raoping Eye study protocol version 5 K.2. INTER-OBSERVER VARIATIONS FORM

Raoping Eye study protocol version 5 K.3. THE CARD OF URGENT CONTACT TOR PARTICIPATIONS

受檢者登記卡片

檢查人員保存

受檢者 ID： 住址： 檢查日期： 受檢者姓名： 年齡： 性別 檢查者視力：① ≥6/18 ② ＜6/18 檢查者白內障手術情況：①至少一隻眼已行白內障手術 ② 雙眼均未行白內障手術 檢查者初步診斷：① 正常 ② 白內障 ③ 其他眼病： 是否需要進一步至醫院檢查眼睛：① 是 ② 否

被檢人員保存

受檢者 ID： 受檢者姓名： 檢查日期： 對您此次檢查的初步診斷為：① 正常 ② 白內障 ③ 其他眼病： 對您是否需要進一步至醫院檢查眼睛的建議：① 是：ⅰ三饒衛生院 ⅱ汕頭國際眼科中心 ② 否 如果您有緊急情況需要我們幫助，或向我们咨询一些眼科的科普知识及此次检查的一些资

料，可以聯繫我們。联系方式為： 地址：潮南区人民院 周醫生

/亮睛工程（汕头办）張銘，謝哲祥 聯繫方式：Tel:0754-88393573

Fax:0754-88393571

Raoping Eye study protocol version 5 K.4. PATIENT INFORATION SHEET

Rapid Assessment of Avoidable Blindness in Chaonan

County

Information for participants

潮南区防盲普查致患者资讯

我们邀请您参加这次潮南区地区眼病普查工作，目的是想了解潮南区地区 村民的视力状况，有多少人是因为眼病看不见。

这个项目是由香港亮睛工程、潮南区残联和潮南区卫生局共同主办的。

2004年开始亮睛工程在建立了亮睛点，为广大患者施行低收费白内障手术， 迄今，已有超过7000人接受了白内障手术。我们此次旨在检查有多少人视力不 好，患有眼疾。

如果您同意参加，我们将为您检查视力和做一些常规的眼科检查，并向您了 解一下生活中用眼情况，此次检查均为无创检查，且为免费，我们将严格保密您 的个人资料，此次眼科检查活动不涉及任何经济利益。

同时，您也可以向我们咨询一些眼科的科普知识及此次检查的一些资料，联 系方式： 潮南区人民医院 亮睛工程（汕头办）

Tel:0754-88393573 Fax:0754-88393571

Raoping Eye study protocol version 5 K.5. CONSENT FORM

潮南区地区防盲调查的患者知情同意书

本人 编号（ ）同意此次检查。

我已对此次眼病检查及调查工作的情况知晓，并向有关工作人员了解了此 次检查目的，以及检查过程中需要配合的注意事项，包括对检查过程中出现可

能造成的已知或未知的事情均以了解。

我自愿参加该调查工作，并明白任何时候也可以选择退出。

我知晓有关我的个人资料将得到保密。

我同意参加，并在此签名。

参加者签名（或按手印）： 日期：

见证人签名： 日期：

调查者签名： 日期：

Raoping Eye study protocol version 5