Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2

NCT06934577 | Recruiting DMC

• 3 other identifiers: HUM002672291 U01DP006826-01-001U01DP006826-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Diseases; Visual Impairment; Glaucoma

Keywords

Eye disease screening; Glaucoma detection

Outcome Measures

Primary Outcomes (4)

• Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)

  Visit 1(day 1)

• Rate of glaucoma/suspected glaucoma

  Visit 1 (Day 1)

• Rate of visually significant cataract

  Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology.

  Visit 1(day 1)

• Rate of diabetic retinopathy

  Visit 1(day 1)

Secondary Outcomes (2)

• Visual Function

  6 weeks

• Rate of disease in second allocation

  6 weeks

Study Arms (2)

Control, standard optometric examination

EXPERIMENTAL

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

Other: Standard optometric examination; Other: Technology enhanced eye disease detection protocol

Intervention, technology enhanced eye disease detection protocol

EXPERIMENTAL

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).

Other: Standard optometric examination; Other: Technology enhanced eye disease detection protocol

Interventions

Technology enhanced eye disease detection protocol OTHER

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 (no disease detected) or an in-depth appointment with the optometrist (disease detected). During the first visit, participants receive care navigation support to purchase low-cost glasses from an on-line retailer. When participants return for the optometrist exam, glasses will be fit. Participants will receive care navigation support to attend any recommended specialty follow-up appointments.

Control, standard optometric examination; Intervention, technology enhanced eye disease detection protocol

Standard optometric examination OTHER

Participants will see the optometrist at the Federally Qualified Health Center. The guidelines define usual care as: an in-person comprehensive eye examination with assessment of patient history, visual acuity, pupil examination, ocular motility and alignment, intraocular pressure, and biomicroscopy with additional tests, as appropriate. A glasses prescription will be given to the participant if needed. Participants will complete surveys at baseline before their eye exam and 6 weeks after the eye exam.

Control, standard optometric examination; Intervention, technology enhanced eye disease detection protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog

You may not qualify if:

• significant eye pain
• sudden decrease in vision within one week
• binocular diplopia
• cognitive impairment
• pregnancy
• previously declined participation

Sponsors & Collaborators

• University of Michigan: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Hamilton Optometry Clinic

Flint, Michigan, 48505., United States

RECRUITING

MeSH Terms

Conditions

Eye Diseases; Vision Disorders; Glaucoma

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Hypertension

Study Officials

• Paula Anne Newman-Casey, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Winter, MS

CONTACT

734-763-6967; wsuzanne@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician assessing the main outcome measure will be masked. A second statistician, not masked to treatment allocation, will tabulate weekly reports of adverse events by treatment group for review by the medical monitor.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology and Visual Sciences

Model Details: Participants meeting inclusion criteria who are 18 years of age or older will be randomized to either 1) control group: standard optometric examination or 2) intervention group: technology-enhanced eye disease screening protocol. Randomization will be stratified by disease risk in two strata: 1) those with and without diabetes, and 2) those \< age 40 and those ≥ age 40. After stratification, participants will be block randomized to the control or intervention arm.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 18, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)