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Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome

NCT07490444 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Refractive Error Correction
  • Visual Acuity

Interventions

DEVICE

Metric-optimized spectacles

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

DEVICE

Routine Clinical Spectacles

Routine clinical spectacles are glasses made from a prescription based upon findings that are obtained during a routine eye examination, including autorefraction measures.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2027-12-01
Completion
2028-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490444 on ClinicalTrials.gov