NCT05425589

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 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

October 1, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

6.3 years

First QC Date

March 29, 2022

Last Update Submit

June 15, 2022

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Adjustable strabismus surgery

OTHER

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

Interventions

Adjustable strabismus surgeryPROCEDURE

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

Adjustable strabismus surgery

Eligibility Criteria

Age5 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Central Study Contacts

Sana Nadeem, MBBS, FCPS, ACMEd

CONTACT

+92515788162sana.nadeem@fui.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, interventional study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

June 21, 2022

Study Start

October 1, 2017

Primary Completion

January 1, 2024

Study Completion

October 1, 2024

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

PA(1)