Lateral Rectus Muscle Tendon Elongation

Lateral Rectus Muscle Tendon Elongation by an Auto Graft From the Resected Medial Rectus Muscle as a Monocular Surgery for Large Angle Sensory Exotropia

To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; Ocular Discomfort; Strabismus, Divergent
• Intervention / Treatment: Procedure: LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE

Detailed Description

A prospective study done in Tanta university in the period between January 2017 and June 2018.It included 16 patients with sensory exotropia ≥50PD. Full history was taken. Visual acuity, cycloplegic refraction and fundus exam of both eyes was performed prior to surgery. Strabismus angles were measured at near and distance by alternate prism cover test. Any limitation of adduction or abduction was scaled from -4 to 0. Patients were followed for 6 months.

SURGICAL PROCEDURE:

The MR muscle was dissected through a limbal incision. Two single arm 6-0 Vicryl sutures were placed at desired distance from the insertion as the routine resection of rectus muscle and another pair of 6-0 Vicryl was placed at the insertion. The muscle was then incised from its insertion, and the posteriorly (distally) placed 6-0 Vicryl sutures were passed through the original insertion. The resected segment is then put in saline. A vicryl 6-0 suture was tied at the LR muscle insertion. The muscle was incised from its insertion. Next, the stump of the resected segment was then sutured to the sclera at the desired position measured by the strabismus caliber according to the surgical dosage sufficient to correct the premeasured distant angle (taking into consideration the length of the added segment, which will be added to the amount of recession), and the distal end of this stump was sutured with the proximal end of LR with the 6-0 Vicryl already placed on the LR. Now the elongated muscle was sutured at desired site from the original insertion of LR as done in routine rectus muscle recession.

The patients were followed at 1day after surgery, 2 weeks, 3 month, and 6 months.

In each visit the distant angle of deviation was measured by prism cover test, any limitation of adduction and abduction was scaled, and patient satisfaction with results at last follow up was obtained, all results were recorded and tabulated.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD.

Exclusion Criteria:

• Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia)
• Angle of deviation less than 50 PD.
• visual acuity more than 0.2 decimal in affected eye .
• A or V pattern exotropia.
• Nystagmus .
• Refusal of surgery by the adult patients or caregiver of children.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .; Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD, were included in the study.

Procedure: LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE; After resection of the medial rectus muscle, the resected segment is sutured to the lateral rectus muscle after dissection and marking to elongate and slaken the muscle then the elongated muscle is sutured to the sclera at the desired amount of conventional recession.; Other Names: Lateral rectus elongation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant angle of deviation after surgical correction	Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.	6month
limitation of adduction and abduction	measured by a scale from -4 to 0; with-4 implying no adduction or abduction beyond midline, -3 implying for 75% deficit,-2 for 50% deficit,-1 for 25% deficit and 0 for full ductions.	6month
patient satisfaction with the procedure	score assesed by questionnaire of 3questions based on satisfaction with degree of alignment, aesthetic appearance, limitation of adduction and abduction. 0: I am not satisfied, 1: I am moderately satisfied, 2: I am satisfied, 3: I am very satisfied, and Iwould recommend it to another. Based on the score (0-3 unsatisfied, 4-6 moderately satisfied, 7-9 very satisfied).	after 6 month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: AUTOGRAFT; SENSORY EXOTROPIA; LATERAL RECTUS ELONGATION
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: 21423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: share data after publication
• IPD Sharing Time Frame: within 6 month of completion of the study
• IPD Sharing Access Criteria: after publication in a subspecialized journal reviewed by panel reviewers that has an open access on line
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR