"My Eyes, My Light": Amar Chokh, Amar Alo

NCT07135570 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2025-08-22

No results posted yet for this study

Summary

Eye disease affects 2.2 billion people globally, which in turn adversely affects schooling, economic productivity, and participation in social life. The primary conditions contributing to visual impairment and blindness include cataracts, age-related macular degeneration (AMD), glaucoma, diabetic retinopathy (DR), refractive error, and presbyopia. Early detection of eye disease can provide substantial benefits in prompting treatment to reduce progression and mitigate disability.

Compared with other regions, South Asia has the most cases of visual impairment due to cataracts and uncorrected refractive error. The combination of poverty, poor living and working environments, and limited health care access have long endangered eye health in Bangladesh. Coastal Bangladesh is particularly impacted by eye disease due to economic deprivation and limited healthcare access. The coastal population mostly works in fishing and agriculture, have prolonged sunlight exposure, and inadequate occupational eye protection. This low-lying region, with 35 million people, is especially vulnerable to climate disasters and global warming. High rates of chronic disease, especially diabetes mellitus Type 2 and hypertension, coupled with limited screening and treatment, shape the area's health profile, with the increasing prevalence of eye diseases such as DR, glaucoma, and visual impairment.

To address the issues of poor health, accessibility, and affordability of eye care, Artificial Intelligence (AI) applications, such as Artificial Intelligence (AI)-assisted fundus imaging, can be applied in eye screening. Medical AI applications have the potential to improve the quality and efficiency of healthcare, reduce healthcare costs, optimize treatment plans, and bolster the development of primary healthcare. They can identify presumptive DR, hypertensive retinopathy (HR), AMD, and glaucoma by analyzing the retina and optic disc of fundus images with moderate accuracy and high efficiency, thus helping address the lack of local eye care professionals.

Data Yakka developed a human-AI collaboration that delivers affordable and transformative community-based eye screening to underserved communities in the coastal Bangladesh region of Char Fasson. The "Amar Chokh Amar Alo" (My Eyes, My Light) initiative creates and implements comprehensive eye screening that combines AI-assisted eye screening and grassroots partnerships with trusted non-health non-governmental organizations (NGOs). It has three objectives: 1) Enhancing accessibility and affordability of eye screening; 2) Supporting high quality and efficient treatment of those problems detected via screening, 3) Collecting fundus images to refine or train AI algorithms in the future. This project was designed to evaluate the feasibility, performance, equity, and cost of this model of eye screening and its implications for global eye disease.

The implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Based on risk stratification by diabetes, hypertension, age 50+ years, and/or optometrist recommendation, fundus imaging was offered selectively to higher-risk patients.

Conditions

  • Glaucoma
  • Diabetic Retinopathy (DR)
  • Hypertensive Retinopathy
  • Cataract
  • AMD - Age-Related Macular Degeneration
  • Presbyopia
  • Myopia
  • Hyperopia
  • Dacryocystitis

Interventions

DIAGNOSTIC_TEST

Multimodal Screening for Eye Disease

The eye disease screening process involved twelve distinct steps were that organized through a corresponding software platform (electronic health record). These steps included: (1) community awareness campaign, (2) participant registration, (3) blood pressure and finger-stick blood glucose measurement, (4) basic vision test, (5) on-site optometrist evaluation, (6) obtaining informed consent for imaging, (7) fundus imaging, (8) automated AI-based disease detection, (9) on-site ophthalmologist examination, (10) remote eye specialist review, (11) on-site counselor discussion, (12) referral for local surgery. This standardized protocol promoted the alignment of eye screening with data gathering and ongoing follow-up eye care interventions. All participants were offered steps 1 to 5. Those participants eligible for fundus imaging (Steps 6-8) included those with diabetes, hypertension, age 50+, or optometrist recommendation based on presenting symptoms.

PROCEDURE

cataract surgery

Individuals diagnosed with high grade cataracts associated with moderate to sever visual impairment were offered cataract surgery, either through local surgery services or regional specialized vision services.

Sponsors & Collaborators

  • Bangladesh Disaster Preparedness Centre

    collaborator UNKNOWN
  • Data Yakka, Inc.

    lead INDUSTRY

Principal Investigators

  • Randall Scott Stafford, MD, PhD, MHS · Data Yakka, Inc.

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-05
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Bangladesh

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135570 on ClinicalTrials.gov