Lateral Rectus Muscle Tendon Elongation

NCT04286945 | Completed DMC

• 1 other identifier: 21423
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgical Procedure, Unspecified; Ocular Discomfort; Strabismus, Divergent

Keywords

SENSORY EXOTROPIA; LATERAL RECTUS ELONGATION; AUTOGRAFT

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .

OTHER

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

Interventions

LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE PROCEDURE

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.

Also known as: Lateral rectus elongation

SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• Shafik HM, Eldesouky MA, Elbakary MA, Elbedewy HA. Unilateral surgery for pediatric sensory exotropia: clinical characteristics and surgical results. BMC Ophthalmol. 2022 Dec 22;22(1):507. doi: 10.1186/s12886-022-02722-2.

  PMID: 36550417 DERIVED

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: PROSPECTIVE STUDY

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 27, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: within 6 month of completion of the study
• Access Criteria: after publication in a subspecialized journal reviewed by panel reviewers that has an open access on line