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

NCT07135570 | Recruiting

• 1 other identifier: Data Yakka Shashibhushan
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vision care; eye disease screening; cataracts; glaucoma; age-related macular degeneration; refractive error; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Number of individuals screened

  The feasibility goal was to demonstrate that high-quality free services could be provided to the population through the eye screening model's work-flow, computer platform, and use of AI-assisted interpretation of fundus images.

  12 months

Secondary Outcomes (1)

• Eye Disease Prevalence

  12 months

Study Arms (1)

Screening Participants

Screening was open to all individuals with no known eye disease diagnoses, 35 or more years residing in the sub-district (Upazila) of Char Fasson in the Bhola District of coastal Bangladesh.

Diagnostic Test: Multimodal Screening for Eye Disease; Procedure: cataract surgery

Interventions

Multimodal Screening for Eye Disease DIAGNOSTIC_TEST

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.

Screening Participants

cataract surgery PROCEDURE

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.

Also known as: Lens replacement surgery

Screening Participants

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Char Fasson is a sub-district (Upazila) of the Bhola District and has a resident population of 518,792. The combination of poverty, poor living and working environments, and limited health care access have long endangered eye health in coastal Bangladesh. The coastal population mostly works in fishing and agriculture, have prolonged sunlight exposure, and inadequate occupational eye protection. This low-lying region is especially vulnerable to climate disasters and global warming. The region has high rates of chronic disease, especially diabetes mellitus Type 2 and hypertension with high rates of poverty and less accessible healthcare compared to Bangladesh as a whole. While the bulk of the Char Fasson population lives in the southern third of the large island of Dakhin Shahbazpur, the sub-district also includes at least 100 small, remote islands extending into the Bay of Bengal.

You may qualify if:

• Age 35+ years
• Residing in the Sub-District of Char Fasson in the Bhola District

You may not qualify if:

• Known eye disease diagnosis

Sponsors & Collaborators

• Data Yakka, Inc.: lead
• Bangladesh Disaster Preparedness Centre: collaborator

Study Sites (1)

Shashibhushan Clinic

Char Fasson, Bhola, Bangladesh

RECRUITING

Related Publications (3)

• GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.

  PMID: 33275949 BACKGROUND

• Vision Loss Expert Group of the Global Burden of Disease Study; GBD 2019 Blindness and Vision Impairment Collaborators. Global estimates on the number of people blind or visually impaired by diabetic retinopathy: a meta-analysis from 2000 to 2020. Eye (Lond). 2024 Aug;38(11):2047-2057. doi: 10.1038/s41433-024-03101-5. Epub 2024 Jun 27.

  PMID: 38937557 BACKGROUND

• Haque A, Haider D, Rahman MS, Kabir L, Lejano RP. Building Resilience from the Grassroots: The Cyclone Preparedness Programme at 50. Int J Environ Res Public Health. 2022 Nov 4;19(21):14503. doi: 10.3390/ijerph192114503.

  PMID: 36361380 BACKGROUND

Related Links

• General website of Data Yakka, Inc. the sponsor of this study.

MeSH Terms

Conditions

Glaucoma; Diabetic Retinopathy; Hypertensive Retinopathy; Cataract; Macular Degeneration; Presbyopia; Myopia; Hyperopia; Dacryocystitis; Refractive Errors

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hypertension; Lens Diseases; Retinal Degeneration; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Randall Scott Stafford, MD, PhD, MHS

  Data Yakka, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Saidur Rahman, PhD

CONTACT

+880 1711-524722; Saidur1943@gmail.com

Hafizur Rahman

CONTACT

+880 1720-123458; hafiz@datayakka.io

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: January 5, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six-months after the conclusion of ongoing data collection or 1/1/2027, whichever occurs later. Data sharing will continue for 36 months after initiation of the data sharing period.
• Access Criteria: All reasonable requests for research collaboration, so long as two or members of the Data Yakka or employees of the project are included on planned articles.

Locations

BA (1)