Prism Adaptation in Symptomatic Esophoria - Effect of Shorter Time Intervals and Surgical Outcome… (NCT06729710) | Clinical Trial Compass
RecruitingNot Applicable
Prism Adaptation in Symptomatic Esophoria - Effect of Shorter Time Intervals and Surgical Outcomes Based on Prism Adaptation
Denmark100 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients with symptomatic esophoria who meet one or more of the following criteria:
* Double vision
* Asthenopia (eye strain)
* Headaches related to esophoria
* Worsening of symptoms during fatigue, sleep deprivation, reading, illness, or alcohol consumption.
Exclusion Criteria:
* Age between 18 and 65 years at date of inclusion.
* Accommodative esotropia or esophoria
* Myopia exceeding 10 diopters in the most myopic meridian
* Treatment with botulinum toxin in an eye muscle within four months prior to inclusion
* Inability to undergo reliable orthoptic measurements or prism adaptation
* Previous strabismus surgery
* Pregnancy or breastfeeding within 12 months prior to inclusion
* Myogenic disorders (including Myasthenia Gravis)
* Restrictive strabismus (including previous eye muscle trauma or Graves' orbitopathy)
* Eye muscle paresis
* Maximum prism-adapted deviation angle \>40 prism diopters (PD) in any gaze direction for distance
* Maximum prism-adapted deviation angle with ≥20 PD difference between near and distance measurements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reoperation rate
Timeframe: Up to 5 years
2
Measured deviation angle at the conclusion of prism adaptation.