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

NCT06729710 | Recruiting

• 1 other identifier: H-24017032
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophoria

Keywords

Esophoria; prism adaptation; strabismus surgery

Outcome Measures

Primary Outcomes (2)

• Reoperation rate

  Number of patients in need of reoperation after initial surgery for symptomatic esophoria

  Up to 5 years

• Measured deviation angle at the conclusion of prism adaptation.

  Measured deviation angle in prism diopters at the conclusion of prism adaptation.

  Up to 5 years

Secondary Outcomes (3)

• Motor success

  1 year from date of surgery

• Sensory success

  1 year from date of surgery

• Symptomatic success

  1 year from date of surgery

Study Arms (2)

1 hour prism adaptation

ACTIVE COMPARATOR

Patients who receive one hour of prism adaptation.

Procedure: Prism adaptation test; Procedure: other

4 hours of prism adaptation

ACTIVE COMPARATOR

Patients who receive four hour of prism adaptation.

Procedure: Prism adaptation test; Procedure: other

Interventions

Prism adaptation test PROCEDURE

Prism Adapation test for 1 hour in one group, and 4 hours in second group

1 hour prism adaptation; 4 hours of prism adaptation

other PROCEDURE

Surgery based on prism adaptation test of 1 hour in one group and 4 hours in second group

Also known as: Surgery based on prism adaptation test

1 hour prism adaptation; 4 hours of prism adaptation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Accommodative esotropia or esophoria
• Myopia exceeding 10 diopters in the most myopic meridian
• Inability to undergo reliable orthoptic measurements or prism adaptation
• Previous strabismus surgery
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Central Study Contacts

Mikael Hofsli, M.D

CONTACT

004538634381; mikael.hofsli@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)