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

Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Down Syndrome
• Intervention / Treatment: Device: Dilated Refraction; Device: Non-Dilated Refraction

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Texas
    • Houston, Texas, United States, 77004
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dilated first, non-dilated second; 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; 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.; Device: Non-Dilated Refraction; 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.
Experimental: Non-dilated first, dilated second; 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; 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.; Device: Non-Dilated Refraction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity	Near visual acuity (in logMAR) will be measured with a Bailey-Lovie style HOTV card. 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 outcome of interest is the difference in near visual acuity measurements calculated as visual acuity when wearing pre-dilation lens minus wearing post-dilation lens.	1 day
Participant Rating of Distance Vision Quality	Participants will be asked to rate their quality of vision at near on a five-point scale where 1 will correspond to poorest vision and 5 will correspond to best vision. Ratings will be obtained at the end of testing with each spectacle lens (based on pre- and post-dilation refraction).	1 day
Participant Rating of Vision Quality at Near	Participants will be asked to rate their quality of vision at near on a five-point scale where 1 will correspond to poorest vision and 5 will correspond to best vision. Ratings will be obtained at the end of testing with each spectacle lens (based on pre- and post-dilation).	1 day
Participant Overall Preference for Prescriptions	Participants will be asked to select which of the two prescriptions (spectacles based on pre- or post-dilation) are preferred overall.	1 day

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Houston
• Investigators: Principal Investigator: Heather Anderson, OD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Eye Diseases; Congenital Abnormalities; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Down Syndrome; Refractive Errors
• Other Study ID Numbers: EY024590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No