Smartphone Screening for Eye Diseases
1 other identifier
observational
550
0 countries
N/A
Brief Summary
To validate new screening instruments for eye disease, increase eye care access in underserved communities, and provide a scientifically implemented method to set up programs for eye disease screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2015
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
August 20, 2025
August 1, 2025
11.2 years
March 1, 2017
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease diagnosis based on photography
Ophthalmologists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination for agreement between the graders for the diagnosis of eye disease along with the sensitivity and specificity.
The outcome measure will be assessed and data will be presented through study completion, an average of 1 month.
Secondary Outcomes (1)
Automated disease diagnosis
The outcome measure will be assessed and data will be presented through study completion, an average of 1 month.
Study Arms (4)
Diabetic Eye Disease
Photographs will be taken with our smartphone-based camera along with the standard of care, including traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing diabetic retinopathy along with the stage of diabetic retinopathy. Several ophthalmology specialists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of eye disease. We will also assess the sensitivity and specificity of diabetic retinopathy diagnoses with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
Glaucoma
Photographs will be taken with our smartphone-based camera along with the standard of care, including traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing glaucoma. Several ophthalmology specialists will grade the smartphone fundus photographs, the traditional optic disc photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of glaucoma. We will also assess the sensitivity and specificity of glaucoma diagnoses with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
Age related macular degeneration (AMD)
Photographs will be taken with our smartphone-based camera along with the standard of care, including traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing age-related macular degeneration along with the stage. Several ophthalmology specialists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of eye disease. We will also assess the sensitivity and specificity of age-related macular degeneration diagnoses with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
Retinopathy of Prematurity (ROP)
Photographs will be taken with our smartphone-based camera along with the standard of care, including Retcam photography or traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing ROP. Several ophthalmology specialists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of eye disease. We will also assess the sensitivity and specificity of ROP diagnosis with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
Interventions
Fundus photographs will be taken with our smartphone-based camera along with the standard of care, including traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing disease along with the stage of disease. Several ophthalmologists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of eye disease. We will also assess the sensitivity and specificity of diagnoses with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
Eligibility Criteria
The study population will consist of patients recruited from the clinic, inpatient, and operating room settings at the University of Michigan, University of California, and Washington University.
You may qualify if:
- Any patient at least seen in the ophthalmology clinic with eye diseases as a result of diabetes, glaucoma, age related macular degeneration, retinopathy of prematurity, of who is willing to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Washington University School of Medicinecollaborator
- University of California, Berkeleycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yannis Paulus, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 1, 2017
First Posted
March 10, 2017
Study Start
April 16, 2015
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 30, 2028
Last Updated
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share