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Smartphone Screening for Eye Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076697
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Washington University School of Medicine
University of California, Berkeley
Information provided by (Responsible Party):
Yannis Paulus, University of Michigan

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Glaucoma Age Related Macular Degeneration ROP Diabetic Retinopathy Retinal Disease Diagnostic Test: Fundus photography

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smartphone Screening for Eye Diseases
Actual Study Start Date : April 16, 2015
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : August 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Group/Cohort Intervention/treatment
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.
Diagnostic Test: Fundus photography
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.

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.
Diagnostic Test: Fundus photography
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.

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.
Diagnostic Test: Fundus photography
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.

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.
Diagnostic Test: Fundus photography
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.




Primary Outcome Measures :
  1. Disease diagnosis based on photography [ Time Frame: The outcome measure will be assessed and data will be presented through study completion, an average of 1 month. ]
    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.


Secondary Outcome Measures :
  1. Automated disease diagnosis [ Time Frame: The outcome measure will be assessed and data will be presented through study completion, an average of 1 month. ]
    The photographs will be interpreted using computer learning algorithms, and these automated interpretations will be compared to skilled ophthalmologist interpretation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with eye diseases other than what is listed in inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076697


Sponsors and Collaborators
University of Michigan
Washington University School of Medicine
University of California, Berkeley
Investigators
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Principal Investigator: Yannis Paulus, MD University of Michigan

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Responsible Party: Yannis Paulus, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03076697    
Other Study ID Numbers: HUM00097907
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yannis Paulus, University of Michigan:
fundus photography
smartphone-based photography
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Retinal Degeneration
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases