Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome

NCT05059041 | Completed Phase 2 Results

• 1 other identifier: EY024590
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Individuals with Down syndrome (DS) live with visual deficits due, in part, to elevated levels of higher-order optical aberrations (HOA). HOAs are distortions/abnormalities in the structure of the refractive components of the eye (i.e. the cornea and the lens) that, if present, can result in poor quality focus on the retina, thus negatively impacting vision. HOAs in the general population are overall low, and thus not ordinarily considered during the eye examination and determination of refractive correction. However, for some populations, such as individuals with DS, HOAs are elevated, and thus the commonly used clinical techniques to determine refractive corrections may fall short. The most common clinical technique for refractive correction determination is subjective refraction whereby a clinician asks the patient to compare different lens options and select the lens that provides the best visual outcome. Given the cognitive demands of the standard subjective refraction technique, clinicians rely on objective clinical techniques to prescribe optical corrections for individuals with DS. This is problematic, because it may result in errors for eyes with elevated HOA given that these techniques do not include measurement of the HOAs. The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction determination for patients with DS. The specific aim is to determine whether dilation of the eyes is needed prior to objective wavefront measurements. Dilation of the eyes increases the ability to measure the optical quality of the eye and paralyzes accommodation (the natural focusing mechanism of the eye), which could be beneficial in determining refractions. However, the use of dilation lengthens the process for determining prescriptions and may be less desirable for patients.

Conditions

Down Syndrome; Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Distance Visual Acuity

  Distance (in LogMAR) visual acuity will be measured in the right eye with the British Standard Letter set or HOTV Matching for participants unable to name letters. Measurements will be obtained while the participant wears spectacle lenses based on their pre- and post-dilation refractions, respectively (from Visit 1). The order of testing is randomized. The primary outcome is the difference in distance visual acuity measurements calculated as visual acuity when wearing pre-dilation lens minus wearing post-dilation lens.

  1 day

Secondary Outcomes (4)

• Near Visual Acuity

  1 day

• Participant Rating of Distance Vision Quality

  1 day

• Participant Rating of Vision Quality at Near

  1 day

• Participant Overall Preference for Prescriptions

  1 day

Study Arms (2)

Dilated first, non-dilated second

EXPERIMENTAL

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.

Device: Dilated Refraction; Device: Non-Dilated Refraction

Non-dilated first, dilated second

EXPERIMENTAL

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.

Device: Dilated Refraction; Device: Non-Dilated Refraction

Interventions

Dilated Refraction DEVICE

The dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from dilated measures of the eye using a wavefront aberrometer.

Dilated first, non-dilated second; Non-dilated first, dilated second

Non-Dilated Refraction DEVICE

The non-dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from non-dilated measures of the eye using a wavefront aberrometer.

Dilated first, non-dilated second; Non-dilated first, dilated second

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Down syndrome
• Able to be dilated
• Able to fixate for study measures
• Able to respond for visual acuity testing

You may not qualify if:

• Ocular nystagmus
• History of ocular or refractive surgery (strabismus surgery is okay)
• Corneal or lenticular opacities
• Ocular disease

Sponsors & Collaborators

• Ohio State University: lead
• University of Houston: collaborator

Study Sites (2)

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Houston

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Down Syndrome; Refractive Errors

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; Eye Diseases

Results Point of Contact

• Title: Heather Anderson
• Organization: The Ohio State University

anderson.3881@osu.edu

614-247-5825

Study Officials

• Heather Anderson, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: May 6, 2022
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: May 8, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)