Eye Patching + Prism Adaptation for Strabismus

(DESDEE Trial)

No longer recruiting at 9 trial locations

Overseen By Matthew D Gearinger, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Neurological disorder, Prior strabismus surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments—eye patching and prism adaptation (a type of vision therapy)—to assess their effects on divergence excess exotropia, a condition where the eyes drift outward. Researchers aim to determine if these treatments alter the diagnosis to a related condition after 24 hours. Individuals diagnosed with divergence excess exotropia, who have not undergone eye surgery and can see well with glasses, might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to understanding potential new treatments for eye misalignment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that eye patching and prism adaptation are safe for treating strabismus?

Research has shown that both patching and prism adaptation are generally safe for treating eye conditions.

Patching is often used for conditions like amblyopia, or lazy eye, and patients usually tolerate it well. One study found that 98% of patients completed a 5-week patching treatment without major issues. Although rare, some patients might experience a decrease in vision sharpness after stopping treatment.

Prism adaptation has proven beneficial for individuals with spatial neglect, a condition involving difficulty paying attention to one side of space. Patients typically respond well, and healthcare providers express satisfaction with its use.

Overall, both treatments are considered safe and are used in various eye therapies. Consulting a healthcare provider can help determine if these treatments are suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining eye patching with prism adaptation for strabismus because this approach offers a fresh take on treatment. Unlike traditional methods such as corrective glasses, surgery, or vision therapy, this combo targets the brain's adaptability. Eye patching strengthens the underused eye, while prism adaptation helps align vision by shifting images, which can retrain the brain to correct eye misalignment. This dual approach could provide a non-invasive alternative with the potential for faster and more effective results, enhancing the quality of life for those with strabismus.

What evidence suggests that this trial's treatments could be effective for strabismus?

This trial will compare two treatments for strabismus: eye patching and prism adaptation. Research has shown that using an eye patch can help treat strabismus, a condition where the eyes do not align properly, in children. One study found that 81% of children had their strabismus and double vision completely resolved over three years. Another study discovered that starting patching early was more effective than longer use of glasses for children with amblyopia, a vision development issue.

Regarding prism adaptation, studies have shown mixed results. However, it has been used successfully before strabismus surgery to improve outcomes. It also shows promise in helping patients with spatial neglect, a condition where they have trouble seeing one side of space. Both treatments offer potential benefits, but results can vary for each person. Participants in this trial will be assigned to either the patching arm or the prism adaptation arm to evaluate the effectiveness of these treatments. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have never had surgery for crossed eyes.

I can follow instructions for tests.

I have not been diagnosed with dissociated vertical deviation.

Exclusion Criteria

Best-corrected visual acuity in either eye worse than 20/40

I have had surgery to correct eye alignment.

I have been diagnosed with a specific eye misalignment condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo monocular occlusion (patching) for 24 hours or prism adaptation for 7-14 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patching
• Prism Adaptation

Trial Overview

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.

How Is the Trial Designed?

Group I: Prism Adaptation Experimental Treatment 1 Intervention

Group II: Patching Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

In a study of 51 patients with partially accommodative esotropia (PAET), prism adaptation did not significantly affect overall surgical success rates, with both groups achieving similar outcomes one year post-surgery.

However, patients in the prism adaptation group who required additional prism adjustments (prism builders) showed better surgical outcomes, with a higher percentage achieving less than 5 prism diopters of deviation compared to those who did not require additional prism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prism adaptation in patients with partially accommodative esotropia: clinical findings and surgical outcomes. Jang, Y., Lee, HJ., Jung, JH., et al.[2021]

In a study of children undergoing surgery for partially accommodative esotropia, 36% of patients required an increase in prism dosage during the prism adaptation test (PAT), and these patients had a 100% success rate in achieving motor success postoperatively, compared to 56% for those with stable deviation.

The PAT may serve as a useful prognostic tool to identify patients who are likely to benefit from increased surgical dosage, potentially preventing undercorrection, but further randomized studies are needed to confirm its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective evaluation of bilateral medial rectus recession for management of accommodative esotropia according to prism-adapted motor response preoperatively. Quigley, C., Cairns, M., McElnea, E., et al.[2018]

Only 28% of strabismologists and orthoptists in Austria use long-term prism adaptation tests (PAT) before strabismus surgery, with most relying on personal experience rather than scientific evidence.

Current literature shows inconsistent results regarding the effectiveness of PAT, and while it may improve outcomes for specific conditions like acquired esotropia, there is no strong evidence supporting its use for better postoperative results overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prism adaptation test before strabismus surgery : Results of a survey and literature review]. Pichler, U., Rohleder, M., Ehrt, O.[2019]

In a study of 40 patients with acquired comitant esotropia, the prism adaptation method resulted in a significantly higher motor success rate of 90% at 3 months compared to 55% in the augmented surgery group.

While prism adaptation is effective for determining the surgical target angle, the long-term success rates (6 months) were similar between both methods after correcting for hyperopic spectacle power, suggesting that prism adaptation may not be necessary for all cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of Prism Adaptation and the Augmented Surgery Formula in the Management of Acquired Comitant Esotropia. Kassem, RR., Elhilali, HM., El-Sada, MA., et al.[2020]

In a study of 28 patients with acquired nonaccommodative esotropia, a short prism adaptation test (PAT) effectively identified 50% of patients as prism responders, leading to successful surgical outcomes with 100% alignment in this group after 6 months.

The results suggest that PAT may not be necessary for patients with a deviation angle greater than 30Δ, as none of these patients responded to the test, indicating a potential for more straightforward surgical planning in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short prism adaptation test in patients with acquired nonaccommodative esotropia; clinical findings and surgical outcome. Akbari, MR., Mehrabi Bahar, MR., Mirmohammadsadeghi, A., et al.[2019]

In a multicenter clinical trial involving patients with acquired esotropia, those who underwent prism adaptation showed a significantly higher overall success rate of 83% compared to 72% in those who did not, indicating that prism adaptation can improve surgical outcomes.

Among prism adaptation responders, those who received augmented surgery based on their adapted angle had the highest success rate of 89%, suggesting that tailoring surgery to individual responses can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. [2019]

In a study of 15 patients with persistent strabismus, those who underwent prism adaptation before reoperation showed a 67% success rate, compared to 50% in those who did not, but the difference was not statistically significant.

The findings suggest that while prism adaptation may provide some benefits in planning strabismus reoperations, the advantages do not justify the additional time and costs involved, indicating a need for further research with larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the value of prism adaptation in planning strabismus reoperations. Kassem, RR.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38058130/

The efficacy of part-time patching treatment for intermittent ...

Overall, there was no improvement in the angle of deviation but 34% of patients had improved control over the follow-up period. 55.3% of the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1609192/

A Randomized Trial to Evaluate Two Hours of Daily ...

Two hours of daily patching combined with one hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

3.

ajo.com

ajo.com/article/S0002-9394(24)00374-X/fulltext

High-Adherence Dichoptic Treatment Versus Patching in ...

The patching group received 2-hour patching 7 days/week (224 hours). The primary outcome was the mean improvement from baseline in amblyopic eye ...

4.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(23)02893-3/fulltext

Extended optical treatment versus early patching with an ...

The results from this trial indicate that early patching is more effective than EOT for the treatment of most children with amblyopia. Our ...

5.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1582284/full

Non-surgical treatment of strabismus in children: a review ...

The results showed that during a 3-year follow-up period, 81% of the patients experienced complete resolution of both strabismus and diplopia, ...

6.

aao.org

aao.org/education/editors-choice/earlier-eye-patching-may-be-beneficial-children-wi

Earlier Eye Patching May Be Beneficial for Children With ...

Some children with amblyopia may derive more benefit from high-intensity early eye patching than from an extended period of wearing eyeglasses ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24585423/

A comprehensive clinical study about patching after ...

Conclusions: Patching is not necessary for reducing postoperative pain or the risk of infection in children undergoing strabismus surgery.

8.

nature.com

nature.com/articles/s41598-020-79077-5

Fixational eye movements abnormalities and rate of visual ...

In our cohort, 17% of patients had regression with a decrease in visual acuity after stopping patching treatment. All of the patients who ...