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

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Eye Diseases; Visual Impairment
• Intervention / Treatment: Other: Standard optometric examination; Other: Technology enhanced eye disease detection protocol

Detailed Description

See study protocol.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanne Winter, MS; Phone Number: 734-763-6967; Email: wsuzanne@med.umich.edu

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48505.
      • Recruiting
      • Hamilton Optometry Clinic
      • Contact: David Bush, OD; Phone Number: 810-406-4246; Email: david.bush@hamiltonchn.org
      • Principal Investigator: Paula Anne Newman-Casey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control, standard optometric examination; 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; 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.; Other: Technology enhanced eye disease detection protocol; 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.
Experimental: Intervention, technology enhanced eye disease detection protocol; 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; 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.; Other: Technology enhanced eye disease detection protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Function	The Visual Function Questionnaire (VFQ-9) is a 9-item survey that measures vision related quality-of-life and is scored from 0-100, where 100 represents the best visual function and vision-related quality-of-life.	6 weeks
Rate of disease in second allocation	Rate of glaucoma/glaucoma suspect in second allocation	6 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Paula Anne Newman-Casey, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Eye disease screening; Glaucoma detection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Ocular Hypertension; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Eye Diseases; Glaucoma; Vision Disorders
• Other Study ID Numbers: HUM00267229; 1 U01DP006826-01-00 (Other Identifier: Centers for Disease Control and Prevention); 1U01DP006826-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No