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Prevention of Traumatic Corneal Ulcer in South East Asia

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Prevention of Traumatic Corneal Ulcer in South East Asia FROM OUR SOUTH ASIA EDITION Prevention of traumatic corneal ulcer in South East Asia S C AE Srinivasan/ (c)M Country Principal Investigator and Lead Principal Investigator with village health workers in Bhutan Dr. M. Srinivasan ciasis, and leprosy, are declining, and (VVHW) of the Government were utilized Director Emeritus, Aravind Eye Care, soon the majority of corneal blindness will to identify ocular injury and treat corneal Madurai, Tamil Nadu India. be due to microbial keratitis. Most abrasion corneal ulcers occur among agricultural Myanmar: Village Health Workers (VHW) workers in developing countries following of the health department Introduction corneal abrasion. India: paid village volunteers were utilized Corneal ulceration is a leading cause of Several non-randomized prevention visual impairment globally, with a dispro- studies conducted before 2000 Inclusion criteria 2 portionate burden in developing (Bhaktapur Eye Study) and during 2002 • Resident of study area countries. It was estimated that 6 million to 2004 in India, Myanmar, and Bhutan • Corneal abrasion after ocular injury, corneal ulcers occur annually in the ten by World Health Organization(WHO), have confirmed by clinical examination with countries of South East Asia Region suggested that antibiotic ointment fluorescein stain and a blue torch encompassing a total population of 1.6 applied promptly after a corneal abrasion • Reported within 48 hours of the injury billion.1 While antimicrobial treatment is could lower the incidence of ulcers, • Subject aged >5 years of age generally effective in treating infection, relative to neighbouring or historic “successful” treatment is often controls.3-4 Prevention of traumatic Exclusion criteria associated with a poor visual outcome. corneal ulcer adopting the Bhaktapur • Subject not a resident of study area The scarring that accompanies the model in a multicountry study in India, • Presence of clinically evident corneal resolution of infection leaves many eyes Bhutan, Myanmar during 2002 to 2004 infection blind. Thus, prevention of corneal ulcer- was sponsored by WHO. • Penetrating corneal injury or stromal ation is important to reduce morbidity laceration associated with corneal ulceration in Methods • Bilateral ocular trauma countries grouped under South Asian The manpower utilized for this multi- The study was approved by Institutional Association for Regional Cooperation country study to identify ocular injury and Review Boards (IRB) from all the three (SAARC). Traditional infectious causes of treat corneal abrasion is given below: countries. blindness, such as trachoma, onchocer- Bhutan: Volunteer Village Health Workers Table 1. Study design, sample size and Results Bhutan India Myanmar Study design Unmasked Randomized double masked trial Unmasked 111 corneal 338 corneal abrasions Sample size 111 corneal abrasions abrasions Results of Multicountry study No. of ocular injuries 135 1365 273 No. of corneal abrasions 115 409 126 No. of eligible corneal abrasions 115 374 126 Adverse events Nil 04 Nil © The author/s and Community Eye Health Journal 2015. This is an Open Access COMMUNITY EYE HEALTH JOURNAL | VOLUME 29 ISSUE 99 | 2017 S 15 article distributed under the Creative Commons Attribution Non-Commercial License. FROM OUR SOUTH ASIA EDITION Treatment Protocol antibacterial ointment alone, even though vision centre or are found during annual In general, corneal abrasions are treated the region had a high incidence of fungal monitoring visits, but active promotion of with topical antibiotics and cycloplegics. infection. This same trial also found that corneal abrasion care will not be offered. In few centres bandaging the affected eye the incidence of ulcers in villages outside is practiced but it is controversial. 1% the prophylaxis program one was far Methodology – phase II chloramphenicol ointment and 1% clotri- higher; these control villages were neigh- study mazole ointment was used. In Bhutan bouring, but not randomized. To address The study was designed in 2014 in only chloramphenicol was used. In this issue, we proposed a community- consultation with F.I. Proctor Foundation, Myanmar both antibiotic and antifungal randomised trial comparing villages San Francisco. Enrollment began in ointment applied but in India it was randomized to receive an intervention January 2015 and ended in December randomized and one arm was masked to consisting of a trained village eye worker 2016. 42 villages having approximately receive both and in the other arm identifying, escorting or referring the 92 thousand people involved in chloramphenicol and placebo ointment patient from intervention villages to the agriculture work were allotted. were used to find out whether antifungal nearest vision centre run by Aravind Eye Randomization was done to have 50% of prophylax is needed to prevent fungal Care System. There a trained vision the population for intervention (Figure 1 ulcer. Frequency of application of all the technician would confirm corneal b) and rest for non-intervention (Figure 1 drugs was 3 times a day for 3 days, super- abrasion, provide 1% chloramphenical b). Data collection, entry, and analysis will vised by village eye workers for ointment to the eligible, enrolled patients be done at Aravind Eye Care System, compliance. in Madurai district. Control villages Madurai and the project will be completed received no additional intervention. The in 2017. Legal and ethical clearance was Conclusion of primary outcome of corneal ulcer obtained from appropriate authorities. multi-country study prevention will be measured by baseline Details of the study design are in the flow This model of delivering eye care services and annual population-based census chart. (Figure 1) through trained village eye workers and performed in both intervention and grass root health workers is a replicable control villages by masked examiners model for any developing country, from baseline to 24 months. The Primary outcome of the especially for South Asian Association for examiners will examine the eyes of all current study Regional Cooperation (SAARC) (Figure 1 household from intervention and The primary outcome will be the incidence a). Follow up rate on the third day at all non-intervention villages who are of corneal ulceration in the two study centres were more than 98%. No case of suspected of having a corneal ulcer or arms as measured by corneal exami- serious adverse event was reported. injury with torch light and magnifying loup. nation at the base hospital or vision Could prevent developing bacterial and Each resident in the village will be centre with telemedicine facility. In this fungal corneal ulcer using 1% chloram- examined for evidence of corneal opacity study 1% chloramphenicol ointment and phenicol ointment in 96% of patients if and asked about their ocular history. 1% itraconazole ointment is applied 3 reported within 24 hours. Annual visits will occur in villages times a day for 3 days and compliance In Madurai, South India, a clinical trial randomized to the intervention, an active would be checked by village health during the same period demonstrated promotion campaign will be undertaken workers. Any adverse event will be that abrasions randomized to topical to urge residents to notify the village eye informed to the study PI or Aravind Eye antibacterial and antifungal prophylaxis health worker within 24 hours of ocular Hospital and will be taken care at no cost were not significantly less likely to develop trauma. In control villages, abrasions and to the participant. fungal ulcers than those randomized to ulcers will be treated if they present to the Figure 1. Design of the study for intervention and control arms 1 a. Intervention S 16 COMMUNITY EYE HEALTH JOURNAL | VOLUME 29 ISSUE 99 | 2017 FROM OUR SOUTH ASIA EDITION 1 b. Control Manpower twice-yearly refresher trainings Aravind Eye Hospital for treatment 20 paid village workers who have throughout the course of the study. immediately. completed school and are able to fill • Promote awareness of corneal abrasion Verbal consent must be obtained from study forms in English and reside in the intervention in intervention villages only all individuals who present to the village • Accessible by villagers via mobile phone study village. Two supervisors well-experi- eye worker to receive study medication. • Conduct eye examination to diagnose enced in rural eye care work to oversee Possible risks and benefits of receiving corneal abrasion and/or ulcer the workers. the treatment will be explained. For • Assist treatment at vision centre for patients under 18, both the child and one Steps in managing programme corneal abrasion, and follow up with the parent or guardian will provide consent for • Workers attend one week training at patient for three days at the village to Aravind Eye Hospital prior to the study ensure compliance the child’s participation. to learn basic anatomy of the eye, • Motivate patient to return for follow-up We believe the results of this study common corneal and external three days after treatment, assess may emerge as a replicable model to diseases, ocular injuries, vision testing, compliance and perform examination prevent traumatic corneal ulcer, and use of fluorescein strip, simple eye • The patient has developed a corneal reduce corneal blindness in South Asia. medicines application and; attend ulcer or adverse reaction refer to References 1. Whitcher J, Srinivasan M, Upadhyay M. Corneal in Nepal. Br J Ophthalmol. 2001;85:388-392. 4. Maung N, Thant C, Srinivasan M, et al. Corneal blindness: a global perspective. Bull World Health 3. Getshen K, Srinivasan M, Upadhyay M, Priyadarsini ulceration in South East Asia II: A strategy for the Organ. 2001;79(3):214-221. B, Mahalaksmi R, Whitcher J. Corneal ulceration in prevention of fungal keratitis at the village level in 2. Upadhyay M, Karmacharya P, Koirala S, et al. The South East Asia. I: A model for the prevention of Burma. Br J Ophthalmol. 2006;90:968-970. Bhaktapur eye study: ocular trauma and antibiotic bacterial ulcers at the village level in rural Bhutan. Br prophylaxis for the prevention of corneal ulceration J Ophthalmol. 2006;90:276-278.
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