What side effects are associated with this type of intervention?

Monocular occlusion (patching) is commonly used to treat strabismus, particularly in children, and can lead to side effects such as skin irritation around the patched eye, temporary blurred vision, and potential amblyopia if not monitored properly. Prism adaptation, used to correct misalignment, may cause side effects like eye strain, headaches, and double vision (diplopia) if the prisms are not correctly calibrated or if the patient has difficulty adapting to the prisms.

What prior FDA approvals exist?

The FDA has approved several treatments for strabismus, including surgical interventions and non-surgical methods like monocular occlusion (patching) and prism adaptation. Monocular occlusion involves covering one eye to improve alignment and is commonly used in children. Prism adaptation uses prisms to correct the angle of deviation in the eyes, helping to improve binocular vision. These methods are often employed as diagnostic tools to reclassify types of exotropia, such as divergence excess exotropia. While specific FDA approvals for these exact methods are not detailed, they are widely accepted and utilized in clinical practice.

What other types of research exist?

Promising novel alternatives for Strabismus treatment in 2024 include: 1) Adjustable suture techniques in strabismus surgery, which allow for postoperative adjustments to improve alignment outcomes. 2) Botulinum toxin injections, which can temporarily weaken overactive eye muscles and improve alignment. 3) Vision therapy software and virtual reality systems designed to improve binocular vision and eye coordination through interactive exercises. These alternatives offer potential benefits in terms of precision, non-invasiveness, and patient engagement.

← Back to Search

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 below

Select...

I have never had surgery for crossed eyes.

Select...

I have not been diagnosed with dissociated vertical deviation.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

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

0 / 7Eligibility criteria met

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.