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NCT05059041 · ClinicalTrials.gov registry record · Phase 2
Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
A Phase 2 study, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT05059041: Completed Phase 2 study, sponsored by Ohio State University.
NCT05059041 is a Phase 2 study that has completed, run by Ohio State University. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05059041, a Phase 2 study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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 wea
Interventions
- DEVICE Dilated Refraction
- DEVICE Non-Dilated Refraction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-05-06 |
| Est. Completion | 2025-01-24 |
| Phase | Phase 2 |
What the finished NCT05059041 record still lists
NCT05059041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Dilated Refraction is the first listed.
NCT05059041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05059041 about?
NCT05059041 is a clinical study titled "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 qu...
What is the current status of trial NCT05059041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-05-06. Estimated completion is 2025-01-24.
What interventions are being tested in trial NCT05059041?
The interventions under investigation include: Dilated Refraction (DEVICE), Non-Dilated Refraction (DEVICE).
Who is sponsoring clinical trial NCT05059041?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05059041's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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