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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 is a Phase 2 study that has completed, run by Ohio State University. The registered enrollment target is 42 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059041
The ClinicalTrials.gov registry entry for NCT05059041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dilated Refraction is the first listed.
NCT05059041 reports 0 study locations.
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.
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