Muscle Transplantation in Strabismus Surgery

• Sponsor: South Valley University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05827393
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.7
• Patients Per Site Per Month: 1.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Strabismus, Noncomitant	Procedure: muscle transplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia
• Actual Study Start Date: Jul 11, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A 15 patients with large angle esotropia	Procedure: muscle transplantation; the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique
Active Comparator: group B 15 patients with large angle exotropia	Procedure: muscle transplantation; the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique

Outcome Measures

Primary Outcome Measures

1. Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia [one day]

   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

1. assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia [six months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qena University Hospital	Qinā		Egypt

Sponsors and Collaborators

• South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: doaa abody ahmed, assistant lecturer ophthalmology, South Valley University
• ClinicalTrials.gov Identifier: NCT05827393
• Other Study ID Numbers: 155
• First Posted: Apr 25, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Strabismus

Study Results

No Results Posted as of Apr 25, 2023