Telemedicine Screening for Glaucoma

(SIGHT Trial)

Overseen By Suzanne Winter, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Eye pain, Vision decrease, Diplopia, Cognitive impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Standard optometric examination, Technology enhanced eye disease detection protocol for glaucoma?

Research shows that telemedicine programs, like the Technology-Based Eye Care Services (TECS), can effectively detect eye diseases and are comparable to in-person exams, although they are slightly less sensitive for glaucoma. Additionally, using intraocular pressure measurements in telemedicine screenings improves the accuracy of glaucoma diagnoses. ^{1 2 3 4 5}

Is telemedicine screening for glaucoma safe for humans?

The Teleglaucoma Initiative at a Veterans Affairs Hospital evaluated the safety of telemedicine for glaucoma care and found it to be safe for use in delivering specialized eye care to patients. ^{2 4 5 6 7}

How is the telemedicine screening for glaucoma treatment different from other treatments?

This treatment is unique because it uses telemedicine (remote healthcare services) to screen for glaucoma, allowing for early detection in remote or rural areas where access to traditional eye care facilities may be limited. It combines portable devices with telemedicine to improve accessibility and accuracy in diagnosing glaucoma. ^{1 2 4 5 8}

What is the purpose of this trial?

To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.

Research Team

Paula Anne Newman-Casey, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals who visit a Federally Qualified Health Center and are at risk of eye diseases like glaucoma, diabetic retinopathy, or cataracts. Specific eligibility criteria were not provided.

Exclusion Criteria

Cognitive impairment

I experience severe eye pain.

Previously declined participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a standard optometric examination or a technology-enhanced eye disease detection protocol

6 weeks

1 visit (in-person) for initial assessment, followed by additional visits as needed

Follow-up

Participants are monitored for visual function and quality-of-life after intervention

6 weeks

Treatment Details

Interventions

• Standard optometric examination
• Technology enhanced eye disease detection protocol

Trial Overview The study compares two methods to detect eye diseases: a standard optometric exam versus a technology-enhanced detection protocol. It aims to see which method is better at finding the leading causes of blindness.

Participant Groups

Group I: Intervention, technology enhanced eye disease detection protocol Experimental Treatment 2 Interventions

Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected).

Group II: Control, standard optometric examination Experimental Treatment 2 Interventions

Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Glaucoma screening: analysis of conventional and telemedicine-friendly devices. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Methods and Screening Results. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Impact of OCT on Diagnostic Accuracy of the Technology-Based Eye Care Services Protocol: Part II of the Technology-Based Eye Care Services Compare Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Intraocular Pressure Measurements Found in a Population at High Risk for Glaucoma. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Telemedicine model to prevent blindness from familial glaucoma. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Telemedicine screening of glaucoma. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Teleglaucoma Initiative at a Veterans Affairs Hospital: Pilot Safety Data and Early Experience. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Alabama Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (AL-SIGHT): Study Design and Methodology. [2023]