NCT03153423

Brief Summary

To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 5, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

May 11, 2017

Last Update Submit

February 18, 2020

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

  • Risk factors for postoperative overcorrections and under corrections

    as axial length of the globe, age, sex and refractive error

    6 months

Study Arms (1)

Basic intermittent exotropia patients

OTHER
Procedure: Strabismus surgery

Interventions

Strabismus surgeryPROCEDURE

Recession and resection of horizontal extra ocular muscles

Basic intermittent exotropia patients

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Basic type intermittent exotropia

You may not qualify if:

  • previous strabismus surgery restrictive strabismus

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

  • Mohamed F Ibrahiem, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

August 5, 2017

Primary Completion

December 20, 2019

Study Completion

January 14, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

EG(1)