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Risk Factors And Surgical Outcomes Of Strabismus Reoperation

ConditionsStrabismusEsotropiaExotropia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Combined vertical and horizontal strabismus.

Paralytic strabismus.

Restrictive strabismus.

Strabismus associated with neurological or syndromic conditions.

Trial design

Design model

Single group

Treatments tested in this trial

  • Horizontal Strabismus Reoperation

    Procedure/Surgery

    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.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Horizontal Strabismus ReoperationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate Of Surgical Success After Horizontal Strabismus Reoperation

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

Time frame
3 months postoperative

Secondary outcomes

1

Preoperative Angle Of Deviation

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

Time frame
Baseline (preoperative)
2

Age At Primary Strabismus Surgery

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

Time frame
Baseline
3

Presence Of Amblyopia

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

Time frame
Baseline
4

Number Of Extraocular Muscles Operated During Reoperation

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

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: