Lateral Rectus Muscle Tendon Elongation
Primary Purpose
Surgical Procedure, Unspecified, Ocular Discomfort, Strabismus, Divergent
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Procedure, Unspecified focused on measuring SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04286945
Brief Title
Lateral Rectus Muscle Tendon Elongation
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure, Unspecified, Ocular Discomfort, Strabismus, Divergent
Keywords
SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
PROSPECTIVE STUDY
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
Other Intervention Name(s)
Lateral rectus elongation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distant angle of deviation after surgical correction
Description
Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.
Time Frame
6month
Title
limitation of adduction and abduction
Description
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
Title
patient satisfaction with the procedure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Lateral Rectus Muscle Tendon Elongation
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