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

University of Michigan

Status: Enrolling

Conditions: Glaucoma; Visual Impairment; Eye Diseases

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06934577

1U01DP006826-01 (U.S. NIH Grant/Contract)

1 U01DP006826-01-00 (Other Identifier)

HUM00267229

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Control, standard optometric examination

Experimental group

Description:

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

Treatment:

Other: Standard optometric examination

Other: Technology enhanced eye disease detection protocol

Intervention, technology enhanced eye disease detection protocol

Experimental group

Description:

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).

Treatment:

Other: Standard optometric examination

Other: Technology enhanced eye disease detection protocol