Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome

NCT07490444 | Not Yet Recruiting Phase 2 FDA Device

• 2 other identifiers: 2021H0128R01EY024590
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Down syndrome; Children; Glasses; Spectacles; Vision

Outcome Measures

Primary Outcomes (1)

• Adapted Distance Visual Acuity

  Aided LogMAR distance visual acuity obtained with either British Standard Letters or HOTV - matching for participants unable to name letters

  2 months

Secondary Outcomes (4)

• Initial Distance Visual Acuity

  1 day

• Near Visual Acuity

  2 months

• Spectacle Wear Time

  2 months

• Participant Survey

  2 months

Study Arms (2)

Metric-Optimized First, Clinical Second

EXPERIMENTAL

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.

Device: Metric-optimized spectacles; Device: Routine Clinical Spectacles

Clinical First, Metric-Optimized Second

EXPERIMENTAL

Participants will be dispensed the clinical spectacle refraction for the first two months followed by the metric-optimized correction for the second two months.

Device: Metric-optimized spectacles; Device: Routine Clinical Spectacles

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, VSX, as determined by algorithms utilizing wavefront aberration measures of the eye

Clinical First, Metric-Optimized Second; Metric-Optimized First, Clinical Second

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.

Clinical First, Metric-Optimized Second; Metric-Optimized First, Clinical Second

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Down syndrome Age 5 to 12 years Ability to sit for study measures Able to be dilated

You may not qualify if:

• Nystagmus History of Ocular or Refractive Surgery Corneal or lenticular opacities Ocular disease Anisometropic or strabismic amblyopia Contact allergy to aluminum

Sponsors & Collaborators

• Ohio State University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Central Study Contacts

Heather Anderson, OD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)