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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

Study 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.Check my eligibility
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.See study design
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

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

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
829 Previous Clinical Trials
505,703 Total Patients Enrolled
1 Trials studying Refractive Errors
294 Patients Enrolled for Refractive Errors
University of HoustonOTHER
147 Previous Clinical Trials
47,442 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What possible risks accompany Non-Dilated Refraction?

"While Phase 2 clinical trials have yet to produce evidence of Non-Dilated Refraction's efficacy, the available data does suggest that it is safe. For this reason, our team at Power has rated its safety a 2 on a scale from 1 to 3."

Answered by AI

Are opportunities available for individuals to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial first appeared on May 6th 2022 and was most recently modified 10 days later. 40 participants are required between two medical sites for successful completion of this experiment."

Answered by AI

How many participants are taking part in this experimental program?

"Yes, according to clinicaltrials.gov the trial that first went live on May 6th 2022 is currently looking for volunteers. The study needs a total of 40 participants from two different sites."

Answered by AI
~14 spots leftby Apr 2025