Prevalence of blindness, visual impairment and main avoidable causes in Chao Nan area Department Ophthalmology 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 Eye 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 & Visual Field 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 Disability 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 Visual acuity, 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 cataract program with more efficiency and higher quality. It will provide important public health 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 aphakia and pseudophakia; 4) Cataract surgical rate and coverage Chaonan RAAB protocol version 4 5 5) Visual outcome of cataract surgery 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 Asia, 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 eyes 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