NCT04617158

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

October 30, 2020

Last Update Submit

April 21, 2022

Conditions

Strabismus, Comitant

Outcome Measures

Primary Outcomes (1)

  • Alignment of the strabismus

    Percentage of patients with successful postoperative alignment using prism cover test for measurement

    3 months

Study Arms (2)

Early adjustable suture surgery

ACTIVE COMPARATOR

Suture adjustment after 2 hours of surgery

Procedure: Adjustable strabismus surgery

Late adjustable suture surgery

ACTIVE COMPARATOR

Suture adjustment after 24 hours of surgery

Procedure: Adjustable strabismus surgery

Interventions

Adjustable strabismus surgeryPROCEDURE

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

Early adjustable suture surgeryLate adjustable suture surgery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with previous strabismus surgery Patients with oblique deviations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Minia University

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sahar TA Abdelaziz, MD

    Faculty of Medicine, Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

December 1, 2019

Primary Completion

January 20, 2022

Study Completion

April 10, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

EG(1)