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Muscle Transplantation in Strabismus Surgery

Primary Purpose

Strabismus, Noncomitant

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
muscle transplantation
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus, Noncomitant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with esotropia or exotropia of more than 60 prism dioptre Exclusion Criteria: Muscular paralysis. High myopia. .Dissociated vertical divergence. .Accommodative esotropias. Large vertical deviations associated Alphabetic syndromes previous surgeries in either eye

Sites / Locations

  • Qena University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

15 patients with large angle esotropia

15 patients with large angle exotropia

Outcomes

Primary Outcome Measures

Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
the change of angle of strabismus will be assessed pre and post muscle transplantation procedure , the angle of strabismus will be measured pre operative and postoperative after one day using hirschburg test measured by degree

Secondary Outcome Measures

assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
the stability of angle of strabismus will be assessed post muscle transplantation procedure , the angle of strabismus will be measured after six month post operative using hirschburg test measured by degree

Full Information

First Posted
February 19, 2023
Last Updated
April 11, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05827393
Brief Title
Muscle Transplantation in Strabismus Surgery
Official Title
Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Noncomitant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
15 patients with large angle esotropia
Arm Title
group B
Arm Type
Active Comparator
Arm Description
15 patients with large angle exotropia
Intervention Type
Procedure
Intervention Name(s)
muscle transplantation
Intervention Description
the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique
Primary Outcome Measure Information:
Title
Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
Description
the change of angle of strabismus will be assessed pre and post muscle transplantation procedure , the angle of strabismus will be measured pre operative and postoperative after one day using hirschburg test measured by degree
Time Frame
one day
Secondary Outcome Measure Information:
Title
assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
Description
the stability of angle of strabismus will be assessed post muscle transplantation procedure , the angle of strabismus will be measured after six month post operative using hirschburg test measured by degree
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with esotropia or exotropia of more than 60 prism dioptre Exclusion Criteria: Muscular paralysis. High myopia. .Dissociated vertical divergence. .Accommodative esotropias. Large vertical deviations associated Alphabetic syndromes previous surgeries in either eye
Facility Information:
Facility Name
Qena University Hospital
City
Qinā
Country
Egypt

12. IPD Sharing Statement

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Muscle Transplantation in Strabismus Surgery

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