NCT05827393

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

February 19, 2023

Last Update Submit

April 11, 2023

Conditions

Strabismus, Noncomitant

Outcome Measures

Primary Outcomes (1)

  • 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

    one day

Secondary Outcomes (1)

  • assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia

    six months

Study Arms (2)

group A

ACTIVE COMPARATOR

15 patients with large angle esotropia

Procedure: muscle transplantation

group B

ACTIVE COMPARATOR

15 patients with large angle exotropia

Procedure: muscle transplantation

Interventions

muscle transplantationPROCEDURE

the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique

group Agroup B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with esotropia or exotropia of more than 60 prism dioptre

You may not qualify if:

  • Muscular paralysis.
  • High myopia. .Dissociated vertical divergence. .Accommodative esotropias.
  • Large vertical deviations associated Alphabetic syndromes
  • previous surgeries in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena University Hospital

Qina, Egypt

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer ophthalmology

Study Record Dates

First Submitted

February 19, 2023

First Posted

April 25, 2023

Study Start

July 11, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

EG(1)