Refractive and Topographic Changes After Strabismus Surgery

April 8, 2025 updated by: Eman Mohammed Moawad Ahmed, Assiut University

Strabismus, characterized by a misalignment of the eyes, is a common condition that can result in functional and cosmetic issues, often affecting vision and binocular coordination. Strabismus surgery aims to correct the alignment by adjusting the extraocular muscles, but while the primary goal of surgery is to restore ocular alignment, refractive changes may occur as a secondary effect (1).

The traditional view of strabismus surgery is that it is more difficult to plan than to perform. Nevertheless, some complications sometimes have some clinical significance and may affect the visual acuity, physical appearance, and future life of the patients (2).

Refractive changes are among the complications of strabismus surgery. This is mostly attributed to the fact that surgical interventions to the extraocular muscles change the vectorial forces transmitted to the cornea via the scleral pathway (3).

Other theories on this subject include postoperative scleral wound healing, edema in the orbit and eyelids, change in ciliary body blood flow, and change in crystalline lens shape and curvature. In addition, if the anterior ciliary arteries are damaged during strabismus surgery, the supply of the anterior segment may be disrupted and changes in parameters may occur accordingly (4).

Also, surface tension changes in adjacent tissues due to changes in muscle tension after surgery may result in changes in corneal and anterior segment measurements (5).

The timing of refractive changes after surgery also varies. Some patients experience changes in their refractive status shortly after surgery, while others may develop these changes months or even years later. This delayed onset can make it more challenging to identify the precise cause of the refractive shift, as it may not always be immediately apparent following the initial surgical correction (6).

Research shows that post-strabismus surgery can result in myopic shifts, especially in patients with esotropia, and hyperopic shifts in exotropia. Astigmatism can also develop due to corneal shape changes. Preexisting refractive errors, age, strabismus type, surgical technique, and surgeon experience also influence post-surgical changes .

To investigate the refractive changes that occur following strabismus surgery, with a focus on identifying the type and timing of refractive shifts (such as myopia, hyperopia, or astigmatism) and their association with the type of strabismus and surgical technique used.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients diagnosed with concomitant strabismus requiring surgical correction.

Description

Inclusion Criteria:

  • All patients diagnosed with concomitant strabismus requiring surgical correction.
  • Clear ocular media.

Exclusion Criteria:

  • Patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology).
  • Patients who have undergone previous intraocular or strabismus surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
study group
patients diagnosed with concomitant strabismus requiring surgical correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
refractive error
Time Frame: 6 month
spherical equivalent of refractive error (measured in diopters, D) before and after strabismus surgery at different follow-up intervals
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Ref&TopgraphStrabismus Surg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Strabismus Surgery

Subscribe