Comparing Adjustable Sutures Surgery

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04617158

Collaborator

(none)

Enrollment

Location

Arms

28.3

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment

Condition or Disease	Intervention/Treatment	Phase
Strabismus, Comitant	Procedure: Adjustable strabismus surgery	N/A

Detailed Description

Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Jan 20, 2022

Actual Study Completion Date :

Apr 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early adjustable suture surgery Suture adjustment after 2 hours of surgery	Procedure: Adjustable strabismus surgery Adjustable surgery will be done using sliding nose technique using fornix approach
Active Comparator: Late adjustable suture surgery Suture adjustment after 24 hours of surgery	Procedure: Adjustable strabismus surgery Adjustable surgery will be done using sliding nose technique using fornix approach

Arm

Intervention/Treatment

Active Comparator: Early adjustable suture surgery

Suture adjustment after 2 hours of surgery

Procedure: Adjustable strabismus surgery

Adjustable surgery will be done using sliding nose technique using fornix approach

Active Comparator: Late adjustable suture surgery

Suture adjustment after 24 hours of surgery

Procedure: Adjustable strabismus surgery

Adjustable surgery will be done using sliding nose technique using fornix approach

Outcome Measures

Primary Outcome Measures

Alignment of the strabismus [3 months]
Percentage of patients with successful postoperative alignment using prism cover test for measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients

Exclusion Criteria:

Patients with previous strabismus surgery Patients with oblique deviations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine- Minia University	Minya		Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: Sahar TA Abdelaziz, MD, Faculty of Medicine, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sahar T A Abdelaziz, Assistant Professor, Minia University

ClinicalTrials.gov Identifier:

NCT04617158

Other Study ID Numbers:

Minia University 2020

First Posted:

Nov 5, 2020

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Study Results

No Results Posted as of Apr 25, 2022