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CompletedPhase 2

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

Key facts

Who runs it
Ohio State University
Where
Columbus and Houston, United StatesSee the 2 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
42 people enrolled
Started
6 May 2022
Ended
24 Jan 2025
Type of study
Interventional, 2 groups
Treatments tested
  • Dilated Refraction
  • Non-Dilated Refraction
Record updated
8 May 2026

Who can take part

Age
5 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

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

Where in United States

  • Ohio State UniversityColumbus, United StatesNo longer taking part
  • University of HoustonHouston, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Dilated first, non-dilated secondTreatment being tested

    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: Dilated Refraction and Non-Dilated Refraction

  • Non-dilated first, dilated secondTreatment being tested

    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: Dilated Refraction and Non-Dilated Refraction

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome
Record updated
8 May 2026