NCT06729710 Prism Adaptation in Symptomatic Esophoria - Effect of Shorter Time Intervals and Surgical Outcomes Based on Prism Adaptation
| NCT ID | NCT06729710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Esophoria |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-05-19 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06729710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Esophoria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06729710 currently recruiting?
Yes, NCT06729710 is actively recruiting participants. Contact the research team at mikael.hofsli@regionh.dk for enrollment information.
Where is the NCT06729710 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06729710 clinical trial?
NCT06729710 is sponsored by Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 100 participants.