Adjustable Strabismus Surgery

• Sponsor: Foundation University Islamabad (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05425589
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 0.6

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, interventional studyProspective, interventional study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adjustable Strabismus Surgery
• Actual Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Post-operative alignment [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fauji Foundation Hospital	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

• Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Foundation University Islamabad
• ClinicalTrials.gov Identifier: NCT05425589
• Other Study ID Numbers: FUI/CTR/2022/2
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• 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 Jun 21, 2022