Recruiting

Phase 2

Vision OutcomesMetric-Optimized Spectacle Prescriptions for Children With Down Syndrome

Sponsor:

Ohio State University

Code:

NCT07490444

Conditions

Refractive Error Correction

Visual Acuity

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Metric-optimized spectacles

Routine Clinical Spectacles

Study Details

Brief 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

Study ID

NCT07490444

Start date

Jul 13, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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.

Primary outcome measure

Adapted Distance Visual Acuity [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Heather Anderson, OD, PhD

614-247-5825 anderson.3881@osu.edu

Locations

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Heather Anderson, OD, PhD

614-247-5825 anderson.3881@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 20, 2026

Last verified

Jun, 2026

Keywords

Down syndrome
Children
Glasses
Spectacles
Vision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-20.