Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia

NCT06650735 | Active Not Recruiting

• 1 other identifier: MD-328-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection groups then followed up in the clinic for 6 months to compare motor alignment and sensory functions

Conditions

Intermittent Exotropia

Keywords

IXT; lateral rectus recession; medial rectus resection

Outcome Measures

Primary Outcomes (1)

• Motor alignment in primary position

  Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters \& esotropia/phoria ≤ 4 prism diopters

  12 months

Secondary Outcomes (3)

• Palpebral fissure height

  12 months

• Lateral gaze comitance/incomitance

  12 months

• Stereopsis

  12 months

Study Arms (2)

BMR resection

ACTIVE COMPARATOR

Bilateral medial rectus muscle resection

Procedure: BMR resection

BLR recession

ACTIVE COMPARATOR

Bilateral lateral rectus muscle recession

Procedure: BLR recession

Interventions

BMR resection PROCEDURE

Lid speculum will be applied. Fornix conjunctival incision will be used to expose medial rectus muscle. Area that will be resected will be marked using calipers. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle. The muscle then excised anterior to the sutures and the stump cut flush to the sclera. The muscle will be sutured again to the original insertion by scleral sutures which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).

BMR resection

BLR recession PROCEDURE

Lid speculum will be applied. Fornix conjunctival incision will be used to expose lateral rectus muscle. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle close to the insertion. The muscle will then be cut anterior to the sutures flush with the sclera. Calipers will used to mark the new insertion on sclera measured from the stump. The muscle will be sutured again to the new insertion by scleral sutures, which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).

BLR recession

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with basic type intermittent exotropia
• Measurable angle 25-40 prism diopters

You may not qualify if:

• Restrictive or paralytic deviation or if forced duction test is positive on horizontal muscles
• Incomitant deviation, vertical or oblique muscles surgery and significant A or V pattern
• Previous strabismus, orbital or buckle surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

Location

Related Publications (4)

• Choi MY, Hwang JM. The long-term result of slanted medial rectus resection in exotropia of the convergence insufficiency type. Eye (Lond). 2006 Nov;20(11):1279-83. doi: 10.1038/sj.eye.6702095. Epub 2005 Sep 9.

  PMID: 16151478 BACKGROUND

• Wang X, Zhang W, Chen B, Liao M, Liu L. Comparison of bilateral medial rectus plication and resection for the treatment of convergence insufficiency-type intermittent exotropia. Acta Ophthalmol. 2019 May;97(3):e448-e453. doi: 10.1111/aos.14056. Epub 2019 Feb 11.

  PMID: 30740923 BACKGROUND

• Kushner BJ. Selective surgery for intermittent exotropia based on distance/near differences. Arch Ophthalmol. 1998 Mar;116(3):324-8. doi: 10.1001/archopht.116.3.324.

  PMID: 9514485 BACKGROUND

• Pediatric Eye Disease Investigator Group; Writing Committee; Donahue SP, Chandler DL, Holmes JM, Arthur BW, Paysse EA, Wallace DK, Petersen DB, Melia BM, Kraker RT, Miller AM. A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia. Ophthalmology. 2019 Feb;126(2):305-317. doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.

  PMID: 30189281 BACKGROUND

Study Officials

• Yehia Salah Eldeen Mostafa, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: July 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)