Glaucoma Screening for Glaucoma

(G-SEARCH Trial)

Overseen By Dionna Wittberg, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: No phone, No address, Recent optometry

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

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Glaucoma Screening with Optical Coherence Tomography (OCT), Color Fundus Photography, and Tonometry?

Research shows that optical coherence tomography (OCT) is effective in screening for glaucoma, especially in high-risk groups, and can help detect early signs of the disease. Additionally, combining OCT with fundus photography improves diagnostic accuracy, making it a useful tool for glaucoma screening. ^{1 2 3 4 5}

Is glaucoma screening using OCT, color fundus photography, and tonometry safe for humans?

The research articles focus on the effectiveness and diagnostic capabilities of optical coherence tomography (OCT) for glaucoma screening, but they do not provide specific safety data. Generally, OCT, color fundus photography, and tonometry are non-invasive and widely used in eye exams, suggesting they are considered safe for human use. ^{1 3 6 7 8}

How is the glaucoma screening treatment with OCT, color fundus photography, and tonometry different from other treatments?

This treatment is unique because it uses a combination of optical coherence tomography (OCT), which provides detailed images of the eye's structures, color fundus photography to capture images of the retina, and tonometry to measure eye pressure, making it a comprehensive approach for early detection and monitoring of glaucoma. ^{1 3 5 9 10}

Research Team

Jeremy D Keenan, MD, MPH

Principal Investigator

University of California, San Francisco

Yvonne Ou, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for Californians at risk of glaucoma who haven't been diagnosed yet. It's not clear what specific inclusion or exclusion criteria are, but typically participants would need to meet certain age and health requirements.

Inclusion Criteria

I am Hispanic and 65 years old or older.

Must have been seen at the Federally Qualified Health Center (FQHC) within the past month

I am Black and 50 years old or older.

Exclusion Criteria

Patients without a valid phone number or mailing address

Patients who have had an optometry appointment within the past year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants undergo telemedicine-based glaucoma screening using optical coherence tomography, fundus photography, and tonometry

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for outcomes such as cataract surgery, eyeglasses purchase, and quality of life over a 12-month period

12 months

Treatment Details

Interventions

• Glaucoma Screening with Optical Coherence Tomography (OCT), Color Fundus Photography, and Tonometry

Trial Overview The study tests if screening with OCT, color fundus photography, and tonometry can detect glaucoma better than just giving out educational brochures. Participants will be randomly assigned to get screened or receive the brochure.

Participant Groups

Group I: Screening Experimental Treatment 2 Interventions

Group II: Delayed Education Active Control 1 Intervention

The same as the Educational Brochure arm, but delivered at the conclusion of the study.

Group III: Education Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

References

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

Screening for glaucoma in high-risk populations using optical coherence tomography. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Current applications of machine learning in the screening and diagnosis of glaucoma: a systematic review and Meta-analysis. [2020]

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

Progression of Early Glaucomatous Damage: Performance of Summary Statistics From Optical Coherence Tomography and Perimetry. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Use of Optical Coherence Tomography for Early Glaucoma Screening in a Population of Patients with Diabetes. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Applicability of automatic spectral domain optical coherence tomography for glaucoma mass screening. [2022]

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

A comparative effectiveness analysis of visual field outcomes after projected glaucoma screening using SD-OCT in African American communities. [2022]

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

Diagnostic capability of peripapillary retinal thickness in glaucoma using 3D volume scans. [2022]

8. England pubmed.ncbi.nlm.nih.gov

5-year disease progression of patients across the glaucoma spectrum assessed by structural and functional tools. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of relationship between retinal nerve fiber layer thickness progression and visual field progression in patients with glaucoma. [2021]

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

Comparison of Glaucoma Progression Detection by Optical Coherence Tomography and Visual Field. [2022]