Eye Patching + Prism Adaptation for Strabismus

(DESDEE Trial)

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Eye Patching + Prism Adaptation for Strabismus?

Research shows that using prism adaptation before surgery for strabismus can improve surgical outcomes, with higher success rates in patients who respond well to the prisms. This suggests that prism adaptation can help achieve better alignment in patients with certain types of strabismus. ^{1 2 3 4 5}

Is eye patching and prism adaptation safe for humans?

The research on prism adaptation, often used before strabismus surgery, suggests it is generally safe for humans. It is a preoperative tool to help improve surgical outcomes, and while it requires additional time and effort, no specific safety concerns have been highlighted in the studies. ^{1 2 4 5 6}

How does the Eye Patching + Prism Adaptation treatment for strabismus differ from other treatments?

The Eye Patching + Prism Adaptation treatment is unique because it uses prisms before surgery to determine the maximum angle of eye misalignment and improve surgical outcomes, reducing the need for additional surgeries. This approach is different from standard treatments as it helps tailor the surgery to the patient's specific needs, potentially leading to better alignment results. ^{1 2 4 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Prism adaptation test before strabismus surgery : Results of a survey and literature review]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Short prism adaptation test in patients with acquired nonaccommodative esotropia; clinical findings and surgical outcome. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of prism adaptation in patients with partially accommodative esotropia: clinical findings and surgical outcomes. [2021]

6. United States 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of Prism Adaptation and the Augmented Surgery Formula in the Management of Acquired Comitant Esotropia. [2020]