Clinical trial NCT05059041: Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
Official title: Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Down Syndrome
Refractive Errors
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2021-09-28
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: 1 day
Secondary outcomes:
measure: Near Visual Acuity
timeFrame: 1 day
measure: Participant distance vision ranking
timeFrame: 1 day
measure: Participant near vision ranking
timeFrame: 1 day
measure: Participant overall preference for prescriptions
timeFrame: 1 day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: Ohio State University
name: Heather Anderson, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: