Health TrialsbyHealthPanel

The Glaucoma and Retinopathy Screening Study

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

The goal of this clinical trial is to learn if a new screening approach including an artificial intelligence algorithm that analyzes fundus photographs, measurement of eye pressure and visual field testing works to screen for glaucoma.

Participants will:

Have an image of their fundus (back of the eye) taken as part of their diabetic eye screening Have a measurement of their eye pressure If needed, have a test of their side vision using a headset

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system at primary care centers.

Individuals who are able and willing to provide informed consent for participation in the study.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-based glaucoma screening

    Device

    AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening

  • IOP measurement

    Device

    Intraocular pressure measurement by Icare tonometer

  • Virtual Reality Visual Field Testing

    Device

    Virtual Reality Visual Field Testing by the Olleyes device for participants suspected of having glaucoma

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Combined DED and Glaucoma ScreeningExperimental treatment 3 interventions
Group B: DED Screening Only (Control Arm)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Glaucoma detection

This primary outcome measure will assesses the proportion of participants who receive a glaucoma diagnosis in the combined DED and glaucoma screening group compared to the DED-only screening group. Glaucoma diagnosis in the intervention group is based on AI-assisted analysis of fundus photography, intraocular pressure, and virtual reality perimetry testing for confirmation.

Time frame
1 year from initial screening

Secondary outcomes

1

Cost-Effectiveness of Combined Screening vs. DED-Only Screening

Time frame
1 year from initial screening
2

Participant Satisfaction with Screening Process

This measure assesses participant satisfaction with the glaucoma screening process. Satisfaction will be evaluated through a participant satisfaction survey.

Time frame
Day of screening
3

Participant knowledge about glaucoma

This measure assesses participants' knowledge about glaucoma. Knowledge will be assessed through a questionnaire (NEI Glaucoma Eye-Q test).

Time frame
Day of screening

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Centers for Disease Control and Prevention

Collaborator

Source ClinicalTrials.gov
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