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

NCT04213768 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-12-30

No results posted yet for this study

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

Interventions

PROCEDURE

Lateral rectus plication

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.

PROCEDURE

Lateral rectus Resection

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.

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-04-30
Completion
2020-06-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213768 on ClinicalTrials.gov