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NCT Number: NCT06934577

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Optometry Clinic

Flint, Michigan, 48505., United States

Location status: Recruiting

Location contact

David Bush, OD

CONTACT

[email protected]

810-406-4246

Paula Anne Newman-Casey, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Visit 1(day 1)

  2. Rate of glaucoma/suspected glaucoma

    Time frame: Visit 1 (Day 1)

  3. Rate of visually significant cataract

    Time frame: Visit 1(day 1)

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

  4. Rate of diabetic retinopathy

    Time frame: Visit 1(day 1)

Secondary outcomes

  1. Visual Function

    Time frame: 6 weeks

    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.

  2. Rate of disease in second allocation

    Time frame: 6 weeks

    Rate of glaucoma/glaucoma suspect in second allocation

Study contacts

Contact information is provided by the study sponsor or research team.

Suzanne Winter, MS

CONTACT

[email protected]

734-763-6967

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: SIGHT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 18, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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