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NCT Number: NCT07446621

Risk Factors And Surgical Outcomes Of Strabismus Reoperation

Horizontal strabismus, commonly known as inward or outward deviation of the eyes, is a frequent eye condition that may require surgical correction. Although the first surgery is often successful, some patients develop residual or recurrent eye misalignment and require a second operation (reoperation).

This study aims to identify the clinical and surgical factors that may increase the risk of undercorrection, overcorrection, or recurrence after the first surgery. It also evaluates the outcomes and success rate of repeat surgery in patients with horizontal strabismus.

Patients undergoing reoperation will receive a complete ophthalmological examination before surgery. The surgical plan will be individualized based on previous surgical history and current eye findings. All procedures will be performed under general anesthesia by the same surgeon. Participants will be followed for three months after surgery to assess eye alignment, movement, and possible complications.

The results of this study may help improve surgical planning and predict which patients are at higher risk of requiring additional surgery in the future.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Horizontal strabismus, including esotropia and exotropia, represents the most common form of ocular misalignment requiring surgical intervention. Despite advances in surgical techniques, a proportion of patients experience residual deviation, overcorrection, or recurrence after primary surgery, necessitating reoperation. Reoperation presents unique surgical challenges due to altered anatomy, scar tissue formation, possible muscle slippage, and variability in postoperative healing response.

Reported reoperation rates vary across studies and clinical settings, with multiple patient-related and surgical factors implicated in surgical failure. These factors may include age at primary surgery, magnitude of deviation, amblyopia, number of operated muscles, surgical technique, and time interval between surgeries. However, data regarding predictive risk factors and standardized outcome evaluation in reoperated horizontal strabismus remain limited in the local setting.

This prospective interventional study will be conducted at Assiut University Hospital. It will include patients undergoing repeat surgery for correction of horizontal strabismus. Patients with vertical deviations, paralytic or restrictive strabismus, neurological or syndromic associations, or incomplete previous surgical data will be excluded.

Preoperative assessment will include measurement of visual acuity, cycloplegic refraction, anterior and posterior segment examination, evaluation of ocular motility in nine diagnostic positions of gaze, and measurement of angle of deviation using prism and alternate cover test or Krimsky test when appropriate. Documentation of conjunctival scarring and previous surgical details will be performed.

The surgical approach will be individualized according to preoperative findings and prior operative records. Exploration of previously operated muscles will be performed when clinically indicated. Intraoperative forced duction testing will assess muscle tightness. All surgeries will be conducted under general anesthesia by the same surgeon to reduce inter-operator variability.

Participants will be followed postoperatively at 1 day, 1 week, 1 month, and 3 months. Surgical success will be defined as postoperative alignment within ±10 prism diopters of orthotropia at final follow-up. Secondary outcomes include stability of alignment and postoperative complications such as limitation of ocular motility or conjunctival scarring.

Statistical analysis will evaluate associations between demographic and clinical variables and surgical outcomes using multivariate regression to identify independent risk factors for reoperation outcomes.

The findings of this study aim to improve risk stratification, optimize surgical planning, and enhance long-term outcomes in patients undergoing horizontal strabismus reoperation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with horizontal strabismus (esotropia or exotropia).
  • Patients undergoing repeat surgery for correction of residual, recurrent, undercorrected, or overcorrected horizontal strabismus.
  • Availability of sufficient medical records documenting previous strabismus surgery.
  • Ability to attend scheduled postoperative follow-up visits.
  • Written informed consent obtained from the patient or legal guardian.

Exclusion criteria

  • Combined vertical and horizontal strabismus.
  • Paralytic strabismus.
  • Restrictive strabismus.
  • Strabismus associated with neurological or syndromic conditions.
  • Patients with incomplete or insufficient documentation of previous surgical procedures.
  • Patients unwilling or unable to complete follow-up.

Treatment and study plan

Horizontal Strabismus Reoperation

Procedure

Horizontal strabismus reoperation is performed to correct residual or recurrent esotropia or exotropia following previous strabismus surgery. The surgical plan is individualized based on preoperative assessment and prior operative records. Previously operated muscles are explored when limited ocular motility, scarring, or suspected muscle slippage is present. In other cases, surgery may be performed on unoperated horizontal rectus muscles when appropriate. Intraoperative forced duction testing is conducted to assess muscle tightness, and scar tissue is released when indicated. All procedures are performed under general anesthesia by the same surgeon. Postoperative alignment and ocular motility are evaluated during follow-up visits.

Other names: Strabismus Reoperation, Repeat Strabismus Surgery, Horizontal Rectus Muscle Reoperation

Primary outcomes

  1. Rate Of Surgical Success After Horizontal Strabismus Reoperation

    Time frame: 3 months postoperative

    Percentage of participants achieving postoperative ocular alignment within ±10 prism diopters of orthotropia measured using the Prism and Alternate Cover Test at distance fixation.

Secondary outcomes

  1. Preoperative Angle Of Deviation

    Time frame: Baseline (preoperative)

    Angle of ocular deviation measured in prism diopters using the Prism and Alternate Cover Test at distance fixation before surgery.

  2. Age At Primary Strabismus Surgery

    Time frame: Baseline

    Age of the participant at the time of initial strabismus surgery obtained from medical records.

  3. Presence Of Amblyopia

    Time frame: Baseline

    Presence of amblyopia determined by best corrected visual acuity assessment during preoperative evaluation.

  4. Number Of Extraocular Muscles Operated During Reoperation

    Time frame: Intraoperative

    Number of horizontal rectus muscles surgically operated during the reoperation procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Safwat Hamza

CONTACT

[email protected]

01112603390

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Risk Factors And Surgical Outcomes Of Strabismus Reoperation: A Clinical Study

Acronym: RSOR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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