Article Text

Protocol
Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol
  1. Kieran S O'Brien1,
  2. Valerie M Stevens1,
  3. Raghunandan Byanju2,
  4. Ram Prasad Kandel3,
  5. Gopal Bhandari2,
  6. Sadhan Bhandari2,
  7. Jason S Melo1,
  8. Travis C Porco1,4,
  9. Thomas M Lietman1,4,
  10. Jeremy D Keenan1,4
  11. Group Information for the VIEW II Study Group
    1. 1Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA
    2. 2Bharatpur Eye Hospital, Bharatpur, Nepal
    3. 3Seva Foundation, Bharatpur, Nepal
    4. 4Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA
    1. Correspondence to Dr Jeremy D Keenan; jeremy.keenan{at}ucsf.edu

    Abstract

    Introduction The majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level.

    Methods and analysis This protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention.

    Ethics and dissemination The trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings.

    Trial registration number NCT03752840

    • mass screening
    • glaucoma
    • diabetic retinopathy
    • age-related macular degeneration
    • randomised controlled trial
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    Supplementary materials

    • Supplementary Data

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    Footnotes

    • Collaborators Group information for the VIEW II Study Group: Prakriti Acharaya, Manmohan Adhikari, Shree Kanta Adihikari, Deepak Bhattarai, Rabin Bhattarai, Gopal Bhandari, Sadhan Bhandari, Raghunandan Byanju, Ajaya Chaudhary, Bhagiram Chaudhary, Daya Shankar Chaudhary, Kishor Chaudhary, Krishna Raj Dharel, Maria Gautam, Shree Krishna Gautam, Aakriti Ghimire, Bishwash Ghimire, Narayan Ghimire, Ramesh Ghimire, Gaurav Giri, Puspa Giri, Dhanmaya Gurau, Ramesh Gurung, Deepak Kandel, Simanta Khadka, Benju Lamichhane, Pappu Mahato, Pratikshya Neupane, Ram Janaki Panday, Sabina Parajuli, Radhika Devi Poudel, Susmita Poudel, Sangita Pradhan, Suchan Pun, Bishaka Ranabhat, Sudha Ranabhat, Gaurav Rimal, Gopal Sapkota, Subit Sapkota, Ranjeet Shah, Manisha Shrestha, Saraswati Silwal, Amisha Subedi, Pradeep Subedi, Alish Tamang, Dilip Tandukar, Nischal Sharma Wagle, Nilam Kumari Yadav (Bharatpur Eye Hospital, Bharatpur, Nepal); Sailesh Mishra (Nepal Netra Jyoti Sangh, Kathmandu, Nepal); Heidi Chase, Suzanne Gilbert, Lauren Jesudason, Chundak Tenzing (Seva Foundation, Berkeley CA); Shravan Chaudhary, Parami Dhakwha, Ram Prasad Kandel, Prasanna Sharma, Apsara Shrestha (Seva Foundation, Kathmandu, Nepal); Jeremy Keenan, Thomas Lietman, Jason Melo, Kieran O’Brien, Travis Porco, Daniel Schwartz, Riju Shrestha, Robert Stamper, Valerie Stevens (University of California, San Francisco). Data Safety and Monitoring Committee: William Barlow (University of Washington, Seattle, WA, USA; chair); Leslie Hyman (Wills Eye Institute, Philadelphia, PA, USA); Arthur Reingold (University of California, Berkeley, CA, USA); Serge Resnikoff (Brien Holden Vision Institute, Sydney, Australia and International Health and Development, Geneva, Switzerland); Larry Schwab (International Eye Foundation, Kensington, MD, USA); Carrie Thiessen (Yale University, New Haven, CT, USA). Donald Everett (National Eye Institute, Bethesda, MD, USA; programme officer) attends DSMC meetings as a representative for the sponsor; he assists but does not direct the DSMC's deliberations and decisions.

    • Contributors JDK, KSO and VMS contributed to study design and implementation as well as writing of the manuscript. GB, SB, RPK, RB, JSM, TCP and TML were involved in study design and implementation as well as editing the manuscript.

    • Funding Research reported in this publication was supported by the National Eye Institute of the National Institutes of Health under award number UG1EY028097. Funding for OCT devices was provided by Tony and Kaz David, Francesca Applegarth, Carl Zeiss Meditec (grant number: 18G384), and the Francis I Proctor Foundation. Funding for cataract surgery subsidies was provided by Carpenter Elementary School (Park Ridge, IL). Additional support was provided by the Bofinger Glaucoma Research Fund, Fortisure Foundation, Harper-Inglis Memorial for Eye Research, the Peierls Foundation, Research to Prevent Blindness, and That Man May See. Grant or award numbers have been listed in this statement where applicable. The Data and Safety Monitoring Committee, appointed by the NIH, reviewed and approved submitting this manuscript for publication.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study sponsors had no role in study design, data collection, data management, data analysis, data interpretation, manuscript writing, or the decision to submit the report for publication.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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