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Eye Patching + Prism Adaptation for Strabismus (DESDEE Trial)
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior strabismus surgery
No diagnosis of dissociated vertical deviation
Must not have
Prior strabismus surgery
Diagnosed with dissociated vertical deviation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if different methods can change the diagnosis of a condition where eyes drift outward. It focuses on patients with this specific eye issue to find better ways to classify and treat them.
Who is the study for?
This trial is for children under 18 with a specific eye alignment issue called divergence excess exotropia. They must be able to participate in testing, have normal neurological function (except ADHD or autism if they can still cooperate), and have good vision (20/40 or better). Kids who've had previous eye surgery or other types of strabismus aren't eligible.
What is being tested?
The study is looking at how effective two methods are in treating an eye condition where the eyes drift outward. One method involves covering one eye with a patch for 24 hours, while the other uses special lenses called prisms to correct the misalignment temporarily.
What are the potential side effects?
Patching might cause discomfort, skin irritation around the patched area, or temporary changes in vision. Prism adaptation may lead to eyestrain, headaches, dizziness, or nausea as eyes adjust to prism correction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had surgery for crossed eyes.
Select...
I have not been diagnosed with dissociated vertical deviation.
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I have been diagnosed with a specific type of eye misalignment called divergence excess exotropia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery to correct eye alignment.
Select...
I have been diagnosed with a specific eye misalignment condition.
Select...
I am 18 years old or older.
Select...
I have not been diagnosed with divergence excess exotropia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of participants reclassified as divergence excess exotropia
Percent of participants reclassified as simulated divergence excess exotropia
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: Prism AdaptationExperimental Treatment1 Intervention
Group II: PatchingExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patching
2005
Completed Phase 3
~650
Prism Adaptation
2015
N/A
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Strabismus treatments like monocular occlusion (patching) and prism adaptation work by addressing the misalignment of the eyes. Patching involves covering the stronger eye to force the weaker eye to work harder, thereby improving its function and alignment.
Prism adaptation uses prisms to bend light entering the eye, helping to align the images seen by each eye and encouraging proper eye coordination. These treatments are crucial for strabismus patients as they can improve binocular vision, reduce double vision, and enhance overall visual function, leading to better depth perception and quality of life.
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
870 Previous Clinical Trials
549,713 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had surgery for crossed eyes.I can follow instructions for tests.I have had surgery to correct eye alignment.I have been diagnosed with a specific eye misalignment condition.I have not been diagnosed with dissociated vertical deviation.I have a neurological disorder but can still participate in required tests.I am 18 years old or older.I have not been diagnosed with divergence excess exotropia.I have been diagnosed with a specific type of eye misalignment called divergence excess exotropia.I am neurologically normal, except for crossed eyes. ADHD or autism do not exclude me if I can cooperate with tests.I am younger than 18 and can cooperate with tests.
Research Study Groups:
This trial has the following groups:- Group 1: Patching
- Group 2: Prism Adaptation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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