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Optical Correction

Dilated vs Non-Dilated Eye Exams for Down Syndrome

Phase 2
Recruiting
Led By Heather Anderson, OD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether dilation is necessary to get an accurate measure of HOAs in people with Down syndrome.

Who is the study for?
This trial is for individuals with Down Syndrome who can have their eyes dilated, fixate on objects for study measures, and respond to visual acuity testing. It's not suitable for those with involuntary eye movements (ocular nystagmus), past eye surgeries (except strabismus surgery), or conditions like corneal or lenticular opacities and other ocular diseases.
What is being tested?
The study is examining whether dilating the eyes before measuring wavefront errors (distortions in vision) provides a better basis for prescribing glasses compared to non-dilated measurements. This could help improve vision correction in people with Down Syndrome.
What are the potential side effects?
Eye dilation may cause temporary sensitivity to light, blurred vision close-up, and possibly discomfort from the bright lights used during examination. These effects typically subside after a few hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Distance Visual Acuity
Secondary study objectives
Near Visual Acuity
Participant distance vision ranking
Participant near vision ranking
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-dilated first, dilated secondExperimental Treatment2 Interventions
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.
Group II: Dilated first, non-dilated secondExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,121 Total Patients Enrolled
1 Trials studying Refractive Errors
294 Patients Enrolled for Refractive Errors
University of HoustonOTHER
150 Previous Clinical Trials
47,885 Total Patients Enrolled
1 Trials studying Refractive Errors
294 Patients Enrolled for Refractive Errors
Heather Anderson, OD, PhDPrincipal InvestigatorOhio State University

Media Library

Dilated Refraction (Optical Correction) Clinical Trial Eligibility Overview. Trial Name: NCT05059041 — Phase 2
Refractive Errors Research Study Groups: Dilated first, non-dilated second, Non-dilated first, dilated second
Refractive Errors Clinical Trial 2023: Dilated Refraction Highlights & Side Effects. Trial Name: NCT05059041 — Phase 2
Dilated Refraction (Optical Correction) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059041 — Phase 2
~2 spots leftby Jan 2025
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