Eye DiseasesSIGHTNCT06934577
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2
A study testing Standard optometric examination and Technology enhanced eye disease detection protocol in people with Eye Diseases and Visual Impairment, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases, Visual Impairment, Glaucoma
- What is being tested?
- Standard optometric examination and Technology enhanced eye disease detection protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog
Who cannot join
- significant eye pain
- sudden decrease in vision within one week
- binocular diplopia
- cognitive impairment
- pregnancy
- previously declined participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hamilton Optometry Clinic
Flint, Michigan, 48505.
David Bush, OD, 810-406-4246, david.bush@hamiltonchn.org
Paula Anne Newman-Casey, MD
About this study
Official title: 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.
- Conditions
- Eye Diseases, Visual Impairment, Glaucoma
- Being tested
- Standard optometric examination, Technology enhanced eye disease detection protocol
- Keywords
- Eye disease screening, Glaucoma detection
- Medical subject headings
- Eye Diseases, Vision Disorders, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard optometric examinationOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Standard optometric examination; Other: Technology enhanced eye disease detection protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)
Measured: Visit 1(day 1)
Rate of glaucoma/suspected glaucoma
Measured: 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.
Measured: Visit 1(day 1)
Rate of diabetic retinopathy
Measured: Visit 1(day 1)
Secondary outcomes (2)
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.
Measured: 6 weeks
Rate of disease in second allocation
Rate of glaucoma/glaucoma suspect in second allocation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start4 Dec 2025
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Paula Anne Newman-Casey, University of Michigan
- Investigators
- Paula Anne Newman-Casey, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934577
- Sponsor's protocol ID
- HUM00267229
- Other IDs
- 1 U01DP006826-01-00, 1U01DP006826-01
- Acronym
- SIGHT
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT06934577
- Acronym / sponsor ID
- SIGHT / HUM00267229
- Conditions
- Eye Diseases, Visual Impairment, Glaucoma
- Keywords
- Eye disease screening, Glaucoma detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control, standard optometric examination | Experimental | Other: Standard optometric examination, Other: Technology enhanced eye disease detection protocolParticipants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease. |
| Intervention, technology enhanced eye disease detection protocol | Experimental | Other: Standard optometric examination, Other: Technology enhanced eye disease detection protocolParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog
Key exclusion criteria (6 listed)
- significant eye pain
- sudden decrease in vision within one week
- binocular diplopia
- cognitive impairment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard optometric examinationParticipants 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 | Control, standard optometric examination, Intervention, technology enhanced eye disease detection protocol |
| Technology enhanced eye disease detection protocolParticipants 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. | Other | Control, standard optometric examination, Intervention, technology enhanced eye disease detection protocol |
Primary outcome
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)
Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology.
Rate of diabetic retinopathy
Time frame: Visit 1(day 1)
2 secondary outcomes
Visual Function
Time frame: 6 weeks
Rate of disease in second allocation
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paula Anne Newman-Casey, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard optometric examination and Technology enhanced eye disease detection protocol in people with Eye Diseases and Visual Impairment, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Winter, MS (734-763-6967, wsuzanne@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy) (time frame: Visit 1(day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.