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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to detect eye diseases like glaucoma, diabetic retinopathy, and cataracts using a new technology-based method. Participants will undergo either a regular eye exam or one with enhanced technology, which includes detailed eye scans and photos (technology-enhanced eye disease detection protocol). The goal is to determine which method identifies more cases of these eye conditions. Suitable candidates speak English or Spanish and have not experienced recent severe eye pain or a sudden drop in vision. As an unphased trial, this study offers a unique opportunity to contribute to advancements in eye disease detection technology.

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 prior data suggests that this technology-enhanced eye disease detection protocol is safe?

Studies have shown that the technology used in the improved eye disease detection process is reliable. For instance, an artificial intelligence (AI) system for glaucoma screening correctly identified patients with glaucoma 88 to 90 percent of the time. This demonstrates the technology's effectiveness in detecting eye diseases like glaucoma.

The process includes non-invasive tests such as assessing vision clarity, measuring eye pressure, and taking eye photographs. These tests are generally easy to handle and do not cause harm. Although no direct evidence of safety issues in humans exists from these sources, the non-invasive nature of the tests supports their safety.

Overall, the technology-enhanced process appears effective and safe for screening eye diseases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telemedicine screening for glaucoma because it leverages advanced technology to potentially improve early detection of eye diseases. Unlike standard optometric exams that rely on in-person visits and basic tools, this method uses a comprehensive set of digital measurements like visual acuity, intraocular pressure, and optical coherence tomography, all performed by ophthalmic technicians. This approach not only makes screening more accessible, especially in underserved areas, but also helps in quickly identifying those who need urgent care, thereby optimizing the use of healthcare resources. By making eye care more efficient and widespread, this protocol could significantly enhance the early diagnosis and management of glaucoma and other eye conditions.

What evidence suggests that the technology-enhanced eye disease detection protocol is effective for detecting glaucoma, diabetic retinopathy, and cataracts?

Research has shown that technology can more effectively identify eye diseases such as glaucoma and diabetic retinopathy. In this trial, participants in the intervention arm will undergo a technology-enhanced eye disease detection protocol, which includes advanced measurements and imaging techniques. One study found that telemedicine programs can screen and diagnose glaucoma, providing reliable results. Additionally, advanced computer programs in telemedicine have performed well in identifying eye diseases. AI technology has improved the ability to detect early-stage glaucoma. These findings suggest that technology can enhance eye disease detection and potentially lead to better patient outcomes. Meanwhile, participants in the control arm will receive a standard optometric examination. ^{2 6 7 8 9}

Who Is on the Research Team?

Paula Anne Newman-Casey, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. optainhealth.com optainhealth.com/glaucoma-screening-how-ai-is-improving-eye-health-checkups/

AI in Glaucoma Screening: Enhancing Eye Health The results were remarkable: AI not only improved the detection rates of early-stage glaucomatous changes but also significantly reduced the ...

2. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(23)00037-2/fulltext

AI telemedicine screening in ophthalmology: health ... Within ophthalmology, deep-learning models have shown excellent diagnostic performance in the screening of eye diseases, such as diabetic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7187965/

Telemedicine for Glaucoma: Guidelines and Recommendations Results: Teleglaucoma programs can be used for screening, diagnostic consultation, and long-term treatment monitoring.

4. withpower.com withpower.com/trial/phase-eye-diseases-7-2025-90157

Telemedicine Screening for Glaucoma (SIGHT Trial) 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950253525000474

Perspectives on eye care access and telemedicine-based ... MI-SIGHT offered free eye disease screenings, low-cost glasses and for those who screened positive for glaucoma, personalized education, and language-concordant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508556/

Artificial Intelligence and Advanced Technology in Glaucoma Artificial intelligence (AI) has great promise for enhancing glaucoma care through better diagnosis, treatment, and outcome prediction. Even ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06854198

Glaucoma Screening to Enhance At-Risk Californians' Health This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and ...

8. aao.org aao.org/newsroom/news-releases/detail/artificial-intelligence-guided-glaucoma-screening-

Artificial Intelligence-Guided Glaucoma Screening Shows ... Results showed the algorithm correctly identified patients with glaucoma 88 to 90 percent of the time; human graders were correct 79 to 81 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2162098923010319

New Technologies for Glaucoma Detection This review describes some of the most recent advances in the development and application of new technologies for detecting and managing glaucoma.