Metric-Optimized Glasses for Children with Down Syndrome
Official title: Metric-derived Corrections Versus Clinically-derived Corrections for Children With Down Syndrome
Run by Ohio State University · NCT07490444 · Data updated 2026-11-12
This study tests whether glasses prescribed from computer analysis of eye images help improve vision in children with Down syndrome more than glasses prescribed by standard eye exams.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT07490444 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5–12 with Down syndrome who can sit for measurements and tolerate dilation.
✕Probably not a fit
Children who do not show improvement in visual acuity with the metric approach or have conditions outside the study criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial enrolls 24 children with Down syndrome aged 5–12 to compare metric-derived spectacle prescriptions based on wavefront measurements with routine clinical prescriptions. The study uses a randomized, cross-over design over 12 months with five visits per participant, including eye imaging and refractive assessments. An unmasked examiner conducts enrollment measurements, followed by a masked examiner performing the clinical eye exam and outcome assessments such as distance and near visual acuity and binocular function. The trial aims to determine if the metric-derived method can provide better visual outcomes than conventional prescribing techniques.
Why it matters
Potential benefit: If successful, children could achieve clearer vision with glasses tailored by quantitative eye measurements.
How similar studies have gone: Previous related approaches using wavefront measurements have shown promise in some populations, but this specific metric-optimized method for Down syndrome is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Down syndrome * Age 5 to 12 years * Ability to sit for study measures * Able to be dilated Exclusion Criteria: * Nystagmus * History of Ocular or Refractive Surgery * Corneal or lenticular opacities * Ocular disease * Anisometropic or strabismic amblyopia * Contact allergy to aluminum
Where it's running
-
Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Study coordinator: Heather Anderson, OD, PhD
- Email: anderson.3881@osu.edu
- Phone: 614-247-5825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.