Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia

NCT07637253 | Completed

• 1 other identifier: E-96317027-514.10-236883503
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Exotropia is a type of eye misalignment in which one eye turns outward. In some patients, surgery is needed to improve eye alignment and binocular function. Different surgical techniques can be used to strengthen or adjust the eye muscles responsible for eye position. This study compares two surgical approaches used in patients with primary exotropia. In one group, patients undergo medial rectus resection together with lateral rectus recession. In the other group, patients undergo medial rectus plication together with lateral rectus recession. Both procedures aim to improve ocular alignment, but they may differ in their effects on focusing ability, also called accommodation. Before surgery, patients undergo a detailed ophthalmologic and strabismus examination, including measurement of ocular deviation and assessment of accommodative function. After surgery, patients are followed and reassessed to evaluate changes in eye alignment, surgical success, and accommodative parameters. The purpose of this study is to evaluate and compare postoperative eye alignment, surgical success, and changes in accommodative function after these two surgical techniques. The study will help determine whether medial rectus plication and medial rectus resection have different effects on accommodation and surgical outcomes in patients treated for primary exotropia.

Conditions

Strabismus; Strabismus Surgery; Exotropia; Primary Exotropia; Accomodation

Keywords

accomodative amplitude; primary exotropia; exotropia; strabismus surgery; plication; resection

Outcome Measures

Primary Outcomes (1)

• Change in Accommodative Amplitude

  Accommodative amplitude was measured separately in each eye using the minus lens method. Measurements were performed before surgery and during postoperative follow-up. The change in accommodative amplitude was calculated by comparing postoperative values with the baseline preoperative value. Measurements were recorded in diopters.

  Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3

Secondary Outcomes (2)

• Ocular Alignment

  Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3

• Surgical Success

  Postoperative month 3

Study Arms (2)

Resection Group

ACTIVE COMPARATOR

Participants in this arm underwent unilateral lateral rectus recession combined with medial rectus resection for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude.

Procedure: Lateral Rectus Recession combined with Medial Rectus Resection

Plication Group

ACTIVE COMPARATOR

Participants in this arm underwent unilateral lateral rectus recession combined with medial rectus plication for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude.

Procedure: Lateral Rectus Recession combined with Medial Rectus Plication

Interventions

Lateral Rectus Recession combined with Medial Rectus Resection PROCEDURE

Unilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus resection was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by resection. In the resection procedure, the medial rectus muscle was isolated, disinserted, shortened by removing a measured segment according to the planned surgical dosage, and reattached to the sclera. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon.

Resection Group

Lateral Rectus Recession combined with Medial Rectus Plication PROCEDURE

Unilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus plication was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by plication. In the plication procedure, the medial rectus muscle was folded and sutured to strengthen the muscle without complete disinsertion from its original scleral insertion. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon.

Plication Group

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 5 to 40 years.
• Diagnosis of basic primary exotropia.
• Stable deviation angle over three consecutive preoperative visits.
• Deviation angle of at least 20 prism diopters.
• Literacy and cooperation sufficient to perform accommodative amplitude testing.
• Patients who agreed to undergo unilateral horizontal strabismus surgery.
• Written informed consent obtained from the participant and/or legal guardian.

You may not qualify if:

• Spherical refractive error greater than ±5.00 diopters.
• Cylindrical refractive error greater than ±3.50 diopters.
• Best-corrected visual acuity worse than 0.1 logMAR.
• Paralytic or restrictive strabismus.
• Previous strabismus surgery.
• Presence of additional ocular pathology, including glaucoma, cataract, uveitis, scleritis, retinal disease, macular disease, or optic neuropathy.
• History of ocular trauma.
• Axial length greater than 26.5 mm.
• Aphakia or pseudophakia.
• High accommodative convergence/accommodation ratio.
• Presence of systemic disease.
• Use of medications known to affect accommodation, including topical pilocarpine, cycloplegics, tricyclic antidepressants, or anticholinergic agents.
• Incomplete ophthalmologic or accommodative examinations.
• Loss to follow-up.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

University of Health Sciences, Basaksehir Cam and Sakura City Hospital

Istanbul, Basaksehir, 34490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Exotropia; Strabismus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, MD, FEBO

Model Details: Participants with primary exotropia were assigned to one of two parallel surgical groups: medial rectus resection combined with lateral rectus recession or medial rectus plication combined with lateral rectus recession. Surgical outcomes and postoperative accommodative changes were compared between the groups. Participants were allocated sequentially to two parallel surgical groups in alternating order according to enrollment sequence. No randomization procedure was used.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: January 18, 2024
• Primary Completion: June 20, 2025
• Study Completion: August 15, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)