Lateral Rectus Resection Versus Lateral Rectus Plication in Patients With Residual Esotropia

NCT04213768 | Unknown

• 1 other identifier: IR.SBMU.ORC.REC.1398.022
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia will be compared. Methods: In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection are going to be included and randomized into plication and resection groups. The inclusion criteria will be residual esotropia after uni- or bilateral medial rectus recession, or unilateral recession and resection (R\&R). Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, follow up less than three months will be excluded. A comprehensive ophthalmic examinations are going to be conducted preoperatively and at 1, 3 and 6 months' follow-ups. Surgical success rate will be considered in cases with a postoperative eso- or exotropia ≤10pd.

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

• Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit

  6 months

Secondary Outcomes (1)

• Postoperative exodrift

  6 months

Study Arms (2)

Plication

EXPERIMENTAL

Procedure: Lateral rectus plication

Resection

ACTIVE COMPARATOR

Procedure: Lateral rectus Resection

Interventions

Lateral rectus plication PROCEDURE

The technique is the same as resection up to the muscle suturing, in the next step, the sutures is passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle is folded anteriorly by Stevens muscle hook during tightening and fixing the sutures. At the end, conjunctiva is repaired by Vicryl 8-0.

Plication

Lateral rectus Resection PROCEDURE

Following conjunctiva and tendon capsule incision, lateral rectus is hooked and dissected from its surrounding tissues. Then, the muscle is sutured according to the amount of supposed resection from lateral rectus insertion by Vicryl 6-0 (polyglation 910, coated Vicryl®, Ethicon, Blue Ash, OH). Afterwards, the muscle is cut at 1mm anterior to these sutures and the residual muscle is re-sutured to the sclera at its primary insertion. Finally the conjunctiva is repaired using Vicryl 8-0.

Resection

Eligibility Criteria

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

You may qualify if:

• \- residual esotropia after any strabismus surgery

You may not qualify if:

• Subjects with a history of prematurity
• lack of central fixation
• extraocular muscle palsy
• systemic disorders
• ocular disorders
• follow up less than three months

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (2)

Hamideh Sabbaghi

Tehran, Iran

Location

Islamic Republic of Iran

Tehran, Iran

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hamideh Sabbaghi, PhD

CONTACT

989120285930; sabbaghi.opt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Teacher Assistant

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 30, 2019
• Study Start: December 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)