Skip to main content
OpenTrials
Completed

NCT Number: NCT04286945

Lateral Rectus Muscle Tendon Elongation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Lateral rectus elongation

Primary outcomes

  1. Distant angle of deviation after surgical correction

    Time frame: 6month

    Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.

  2. limitation of adduction and abduction

    Time frame: 6month

    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.

  3. patient satisfaction with the procedure

    Time frame: after 6 month

    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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2020
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.