Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard optometric examination, Technology enhanced eye disease detection protocol.
- Who it may be relevant to
- Registry conditions: Eye Diseases, Visual Impairment, Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial
Overview
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.
Interventions
- 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 ey - 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 i
Primary outcome measures
- Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy) [Time frame: Visit 1(day 1)]
- Rate of glaucoma/suspected glaucoma [Time frame: Visit 1 (Day 1)]
- Rate of visually significant cataract [Time frame: Visit 1(day 1)]
- Rate of diabetic retinopathy [Time frame: Visit 1(day 1)]
Secondary outcome measures (2)
- Visual Function [Time frame: 6 weeks]
- Rate of disease in second allocation [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Hamilton Optometry Clinic — Flint
Identifiers
NCT: NCT06934577 · HUM00267229 · 1 U01DP006826-01-00 · 1U01DP006826-01