NCT06729710

Prism Adaptation in Symptomatic Esophoria - Effect of Shorter Time Intervals and Surgical Outcomes Based on Prism Adaptation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective randomized study aiming to investigate the effect of prism adaptation before surgery for symptomatic esophoria on the number of reoperations, the occurrence of over- and under-correction after the first surgery, and symptom resolution. Additionally, we aim to define the optimal duration of prism adaptation.

Detailed description

SUBSTUDY 1 The Optimal Duration of Prism Adaptation in Symptomatic Esophoria Study Design: Prospective, randomized controlled study Patient Group: 100 participants with symptomatic esophoria, randomized into two groups of 50 participants each to undergo either one hour or four hours of prism adaptation. The purpose of this study is to determine the optimal duration of prism adaptation. The hypothesis is that the measured deviation angle is expected to increase after one hour of prism adaptation compared to before prism adaptation. Furthermore, it is expected that the measured deviation angle will not differ significantly between the two randomization groups. The primary endpoint is the measured deviation angle at the conclusion of prism adaptation. The results are highly relevant for accurate surgical dosing (and thus postoperative symptoms and reoperation rates), efficient use of hospital resources, and reduced patient waiting times in the outpatient clinic. SUBSTUDY 2 Strabismus Surgery for Symptomatic Esophoria Based on Prism Adaptation Study Design: Prospective, randomized controlled study Patient Group: 100 participants with symptomatic esophoria, using the same patients and randomization groups as in Substudy 1. The purpose of this study is to investigate the effectiveness of strabismus surgery for symptomatic esophoria based on prism adaptation. Patients randomized in Substudy 2 to either one or four hours of prism adaptation will undergo surgery based on the full prism-adapted angle. The hypothesis for this substudy is that surgical dosing based on one hour of prism adaptation will be equivalent to dosing based on four hours of prism adaptation. The primary endpoint will be the reoperation rate. Secondary endpoints will include comparisons of preoperative surgical planning metrics (target deviation and number of eye muscles operated), symptom resolution after the first surgery, and prism measurements (including rates of over- and undercorrections).

Conditions

• Esophoria

Interventions

Type	Name	Description
PROCEDURE	Prism adaptation test	Prism Adapation test for 1 hour in one group, and 4 hours in second group
PROCEDURE	other	Surgery based on prism adaptation test of 1 hour in one group and 4 hours in second group

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2024-12-11
• Last updated: 2025-07-22

Locations

1 site across 1 country: Denmark