Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome (NCT07490444) | Clinical Trial Compass
RecruitingPhase 2
Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome
United States24 participantsStarted 2026-05-26
Plain-language summary
This study seeks to determine whether glasses prescriptions determined from computer analysis of detailed images of the eyes provide better vision outcomes for children with Down syndrome than prescriptions determined using routine clinical methods.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for children with Down syndrome, what do we know so far about whether this new approach to prescribing spectacles is safe and effective compared to the standard way glasses are prescribed?
2The trial is focused on measuring 'adapted distance visual acuity' — can you explain what that means for my child's day-to-day vision, and why it might matter more than the standard eye chart measurements we're used to?
3How is the way spectacle prescriptions are calculated in this trial different from how my child's glasses would normally be prescribed, and could participating mean their prescription changes in ways that take some adjustment?
4Would my child need to come in for extra visits or testing beyond our usual eye appointments, and is that realistic given everything else we're managing?
5If we decide not to join this trial, what is the current standard of care for correcting refractive errors in children with Down syndrome, and would my child be missing out on anything meaningful by sticking with that approach??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.