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OpenTrials
Completed

NCT Number: NCT05059041

Dilated Versus Non-Dilated Wavefront Corrections for Patients 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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ohio State University, Columbus, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Distance Visual Acuity

    Time frame: 1 day

    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.

Secondary outcomes

  1. Near Visual Acuity

    Time frame: 1 day

    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.

  2. Participant Rating of Distance Vision Quality

    Time frame: 1 day

    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).

  3. Participant Rating of Vision Quality at Near

    Time frame: 1 day

    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).

  4. Participant Overall Preference for Prescriptions

    Time frame: 1 day

    Participants will be asked to select which of the two prescriptions (spectacles based on pre- or post-dilation) are preferred overall.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • University of Houston

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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