Eye Patching + Prism Adaptation for Strabismus
(DESDEE Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester
Disqualifiers: Neurological disorder, Prior strabismus surgery, others
No Placebo Group
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.
12345Is 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.
12456How 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.
12457Eligibility 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.
+4 more
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.
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Prism AdaptationExperimental Treatment1 Intervention
Group II: PatchingExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Queen's UniversityKingston, Canada
University of California Los AngelesLos Angeles, CA
Harvard UniversityBoston, MA
University of Rochester Medical CenterRochester, NY
More Trial Locations
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
References
[Prism adaptation test before strabismus surgery : Results of a survey and literature review]. [2019]Variable preoperative deviations and compensatory mechanisms may cause wrong dosage of strabismus surgery and result in over- or undercorrection. A long-lasting prism adaptation test (PAT) before surgery is supposed to reduce those difficulties and to improve the postoperative results. To date, the use of prism adaptation before surgery has not been systematically examined.
Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. [2019]Prism adaptation, the preoperative use of prisms in acquired esotropia to determine the maximum angle of strabismus and to estimate fusional potential, has been suggested as a method of improving the results of initial surgery and minimizing the rate of reoperation. We performed a prospective, randomized, multicenter clinical trial of the effectiveness of prism adaptation. Two levels of randomization were used. Sixty percent of the patients underwent prism adaptation and 40% did not. Of those who responded to prisms with motor stability and sensory fusion, half underwent a conventional amount of surgery and half underwent augmented surgery based on the prism-adapted angle of deviation. Success rates were highest (54 [89%] of 61 patients) in prism adaptation responders who underwent augmented surgery and lowest (92 [72%] of 127 patients) in patients who did not undergo prism adaptation. Prism responders had better results with augmented surgery than with conventional surgery (54 [89%] of 61 patients vs 53 [79%] of 67 patients, P = .23). Our results indicated a significant beneficial overall effect of prism adaptation in patients with acquired esotropia (success rates, 83% vs 72%, P = .04). Although the process requires some additional time and effort, it appears to result in a higher rate of satisfactory alignment.
A pilot study of the value of prism adaptation in planning strabismus reoperations. [2019]To evaluate the value of prism adaptation in planning strabismus reoperations.
Short prism adaptation test in patients with acquired nonaccommodative esotropia; clinical findings and surgical outcome. [2019]To evaluate the surgical outcomes in patients with acquired nonaccommodative esotropia operated on based on a short prism adaptation test (PAT) and to determine the subgroup of patients most responsive to PAT.
Effect of prism adaptation in patients with partially accommodative esotropia: clinical findings and surgical outcomes. [2021]To assess the effects of prism adaptation on the surgical outcomes of individuals with partially accommodative esotropia (PAET).
A retrospective evaluation of bilateral medial rectus recession for management of accommodative esotropia according to prism-adapted motor response preoperatively. [2018]The prism adaptation test (PAT) is a preoperative tool that may fine-tune surgical dosage and reduce under- and overcorrection in pediatric partially accommodative esotropia; however, it is resource intensive and the benefits are uncertain. PAT involves correction of esodeviation with prisms, with subsequent assessment for and quantification of change in angle of esodeviation, thereby augmenting the surgical target angle in a subset of patients. We evaluated PAT response and postoperative outcomes in a cohort of children who underwent bilateral medial rectus recession and found that 36% of patients showed a requirement for increase of prism dosage to retain orthotropia during PAT; these patients did better than those whose deviation was stable, with postoperative rate of motor success (defined as ≤10Δ esotropia) of 100% versus 56%. PAT may be a useful positive prognostic test, and it also identifies a substantial patient population who may avoid undercorrection, the prism builders. However, this cohort may do better postoperatively regardless of the target angle for surgery. Additional randomized studies are required to demonstrate definitive benefit of PAT. Identification of the builder phenotype prior to commencing adaptation may reduce the workload involved in the PAT technique.
A Comparative Study of Prism Adaptation and the Augmented Surgery Formula in the Management of Acquired Comitant Esotropia. [2020]To compare two methods of surgical augmentation (prism adaptation and the augmented surgery formula) in the management of acquired comitant esotropia.