An interventional study of LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE in Surgical Procedure, Unspecified, Ocular Discomfort and Strabismus, Divergent, sponsored by Tanta University. Completed. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Also known as: Lateral rectus elongation
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.
Time frame: 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.
Time frame: 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).
Time frame: after 6 month
No study locations are listed for this record.
Plan to share: Yes — share data after publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jun 2018, 17 months.
Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 17 months is close to that.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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