Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings

Kieran S O'Brien, Raghunandan Byanju, Ram Prasad Kandel, Bimal Poudyal, Mariya Gautam, John A Gonzales, Travis C Porco, John P Whitcher, Muthiah Srinivasan, Madan Upadhyay, Thomas M Lietman, Jeremy D Keenan, Village-Integrated Eye Worker Trial Group, M Srinivasan, Manmohan Adhikari, Gopal Bhandari, Sadhan Bhandari, Dipak Bhattarai, Rabin Bhattarai, Dikshya Bista, Raghunandan Byanju, Dipak Chapagain, Ajay Kumar Chaudhary, Daya Shankar Chaudhary, Gokul Dahal, Mariya Gautam, Shree Krishna Gautam, Ramesh Ghimire, Gaurav Giri, Puspa Giri, Dhanmaya Gurau, Jeevan Gurung, Vivek Hamal, Deepak Kandel, Sajani Kayastha, Kamal Bahadur Khadka, Pradip Chandara Lamichhane, Tulsi Prasad Parajuli, Bimal Poudyal, Ranjeet Kumar Shah, Niraj Sharma, Prafulla Sharma, Anju Shrestha, Manisha Shrestha, Pradeep Subedi, Rajendra Rijal, Madan Upadhyay, Bill Barlow, Patricia Buffler, Kavita Dhakhwa, Leslie Hyman, Art Reingold, Serge Resnikoff, Larry Schwab, Carrie Thiessen, Nisha Acharya, Sun Cotter, John Gonzales, Jeremy Keenan, Jessica Kim, Salena Lee, Thomas Lietman, Stephen Mcleod, Kieran O'brien, Travis Porco, David Ramirez, Kathryn Ray, Jennifer Rose-Nussbaumer, Jack Whitcher, Donald Everett, Krishna Raj Dharel, Tejendra Bdr Khadka, Chij Kumar Maskey, Sailesh Kumar Mishra, Tirtha Prasad Mishra, Jaya Ram Shrestha, Laximi Charan Shrestha, Unnat Shrestha, Ken Basset, Heidi Chase, Shravan Choudhary, Parami Dhakwa, Lauren Evans, Suzanne Gilbert, Ram Prasad Kandel, Deborah Moses, Chundak Tenzing, Kieran S O'Brien, Raghunandan Byanju, Ram Prasad Kandel, Bimal Poudyal, Mariya Gautam, John A Gonzales, Travis C Porco, John P Whitcher, Muthiah Srinivasan, Madan Upadhyay, Thomas M Lietman, Jeremy D Keenan, Village-Integrated Eye Worker Trial Group, M Srinivasan, Manmohan Adhikari, Gopal Bhandari, Sadhan Bhandari, Dipak Bhattarai, Rabin Bhattarai, Dikshya Bista, Raghunandan Byanju, Dipak Chapagain, Ajay Kumar Chaudhary, Daya Shankar Chaudhary, Gokul Dahal, Mariya Gautam, Shree Krishna Gautam, Ramesh Ghimire, Gaurav Giri, Puspa Giri, Dhanmaya Gurau, Jeevan Gurung, Vivek Hamal, Deepak Kandel, Sajani Kayastha, Kamal Bahadur Khadka, Pradip Chandara Lamichhane, Tulsi Prasad Parajuli, Bimal Poudyal, Ranjeet Kumar Shah, Niraj Sharma, Prafulla Sharma, Anju Shrestha, Manisha Shrestha, Pradeep Subedi, Rajendra Rijal, Madan Upadhyay, Bill Barlow, Patricia Buffler, Kavita Dhakhwa, Leslie Hyman, Art Reingold, Serge Resnikoff, Larry Schwab, Carrie Thiessen, Nisha Acharya, Sun Cotter, John Gonzales, Jeremy Keenan, Jessica Kim, Salena Lee, Thomas Lietman, Stephen Mcleod, Kieran O'brien, Travis Porco, David Ramirez, Kathryn Ray, Jennifer Rose-Nussbaumer, Jack Whitcher, Donald Everett, Krishna Raj Dharel, Tejendra Bdr Khadka, Chij Kumar Maskey, Sailesh Kumar Mishra, Tirtha Prasad Mishra, Jaya Ram Shrestha, Laximi Charan Shrestha, Unnat Shrestha, Ken Basset, Heidi Chase, Shravan Choudhary, Parami Dhakwa, Lauren Evans, Suzanne Gilbert, Ram Prasad Kandel, Deborah Moses, Chundak Tenzing

Abstract

Introduction: Corneal opacity is a leading cause of blindness worldwide. In resource-limited settings, untreated traumatic corneal abrasions may result in infection and ultimately, opacity. Although antimicrobial treatment of corneal ulcers may successfully cure infections, the scarring that accompanies the resolution of infection can still result in visual impairment. Prevention may be the optimal approach for reducing corneal blindness. Studies have employed community health workers to provide prompt administration of antimicrobials after corneal abrasions to prevent infections, but these studies were not designed to determine the effectiveness of such a programme.

Methods and analysis: The Village-Integrated Eye Worker trial (VIEW) is a cluster-randomised trial designed to assess the effectiveness of a community health worker intervention to prevent corneal ulcers. Twenty-four Village Development Committees (VDCs) in Nepal were randomised to receive a corneal ulcer prevention programme or to no intervention. Female Community Health Volunteers (FCHVs) in intervention VDCs are trained to diagnose corneal abrasions, provide antimicrobials and to refer participants when needed. An annual census is conducted over 3 years in all study VDCs to assess the incidence of corneal ulceration via corneal photography (primary outcome). Masked outcome assessors grade corneal photographs to determine the presence or absence of incident corneal opacities. The primary analysis is negative binomial regression to compare the incidence of corneal ulceration by study arm.

Ethics and dissemination: The University of California San Francisco Committee on Human Research, Nepal Netra Jyoti Sangh and the Nepal Health Research Council have given ethical approval for the trial. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.

Trial registration number: NCT01969786; Pre-results.

Keywords: clinical trials; corneal and external diseases.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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