Adjustable Strabismus Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Strabismus
• Intervention / Treatment: Procedure: Adjustable strabismus surgery

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Nadeem, MBBS, FCPS, ACMEd; Phone Number: 1455 +92515788162; Email: sana.nadeem@fui.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Fauji Foundation Hospital
      • Contact: Sana Nadeem, MBBS, FCPS,; Phone Number: 1455 +92515788162; Email: sana.nadeem@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 69 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adjustable strabismus surgery; Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.	Procedure: Adjustable strabismus surgery; Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus
• Other Study ID Numbers: FUI/CTR/2022/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No