search
Back to results

Adjustable Strabismus Surgery

Primary Purpose

Strabismus

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Adjustable strabismus surgery
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus

Eligibility Criteria

5 Years - 69 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Horizontal, vertical and complex strabismus cases (sensory, paralytic, nystagmus, monocular elevation deficit and dissociated vertical/horizontal deviation) were included, along with patients with a previous history of strabismus surgery.

Myasthenia gravis was excluded along with noncooperative children; less than 7 years of age. Those who did not return for a one year follow up also had to be excluded.

Sites / Locations

  • Fauji Foundation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adjustable strabismus surgery

Arm Description

Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.

Outcomes

Primary Outcome Measures

Post-operative alignment
The post-operative alignment at 1 year will be measured and compared with the pre-operative alignment (deviation) to assess success rate.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
June 15, 2022
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05425589
Brief Title
Adjustable Strabismus Surgery
Official Title
Adjustable Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

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

5. Study Description

Brief Summary
Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjustable strabismus surgery
Arm Type
Other
Arm Description
Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.
Intervention Type
Procedure
Intervention Name(s)
Adjustable strabismus surgery
Intervention Description
Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.
Primary Outcome Measure Information:
Title
Post-operative alignment
Description
The post-operative alignment at 1 year will be measured and compared with the pre-operative alignment (deviation) to assess success rate.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Horizontal, vertical and complex strabismus cases (sensory, paralytic, nystagmus, monocular elevation deficit and dissociated vertical/horizontal deviation) were included, along with patients with a previous history of strabismus surgery. Myasthenia gravis was excluded along with noncooperative children; less than 7 years of age. Those who did not return for a one year follow up also had to be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Nadeem, MBBS, FCPS, ACMEd
Phone
+92515788162
Ext
1455
Email
sana.nadeem@fui.edu.pk
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Nadeem, MBBS, FCPS,
Phone
+92515788162
Ext
1455
Email
sana.nadeem@fui.edu.pk

12. IPD Sharing Statement

Learn more about this trial

Adjustable Strabismus Surgery

We'll reach out to this number within 24 hrs