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

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Refractive Errors; Down Syndrome

Treatments: Device: Dilated Refraction; Device: Non-Dilated Refraction

Study type: Interventional

Funder types: Other

Identifiers

NCT05059041

EY024590

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Dilated first, non-dilated second

Experimental group

Description:

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.

Treatment:

Device: Non-Dilated Refraction

Device: Dilated Refraction

Non-dilated first, dilated second

Experimental group

Description:

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.

Treatment:

Device: Non-Dilated Refraction

Device: Dilated Refraction