Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07490444
Phase
PHASE2
Status
Recruiting
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Conditions

  • Refractive Error Correction
  • Visual Acuity

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Metric-optimized spectacles — DEVICE
    Metric-optimized spectacles are glasses made from a prescription determined by the optimization of a metric for retinal image quality, Visual Strehl Ratio (VSX), as determined by algorithms utilizing wavefront aberration measures of the eye
  • Routine Clinical Spectacles — DEVICE
    Routine clinical spectacles are glasses made from a prescription based upon findings that are obtained during a routine eye examination, including autorefraction measures.

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
May 26, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Metric-Optimized First, Clinical Second
    Participants will be dispensed the metric-optimized spectacle correction for the first two months followed by the clinically determined spectacle correction for the second two months.
  • Experimental: Clinical First, Metric-Optimized Second
    Participants will be dispensed the clinical spectacle refraction for the first two months followed by the metric-optimized correction for the second two months.

Primary Outcome Measure

Adapted Distance Visual Acuity [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210
Heather Anderson, OD, PhD
[email protected]
614-247-5825

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By research site
Ohio State University· Columbus, OH

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