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CompletedNCT03153423Updated Feb 20, 2020

Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction

An interventional study of Strabismus surgery in Strabismus, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 25 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Ages
3 Years to 25 Years
Sex
All
01

Study 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

02

Conditions studied

  • Strabismus
03

Who can participate

Ages eligible
3 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Basic type intermittent exotropia

Exclusion criteria

Exclusion Criteria:

  • previous strabismus surgery restrictive strabismus
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Other
    Basic intermittent exotropia patients

    Procedure: Strabismus surgery

Interventions

  • ProcedureStrabismus surgery

    Recession and resection of horizontal extra ocular muscles

05

What researchers measure

Primary outcomes

  1. Risk factors for postoperative overcorrections and under corrections

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

    Time frame: 6 months

06

Study locations

1 site
  • Faculty of medicine - Minia University
    Minya, 61111, Egypt
07

Registry details

Key details

Study ID
NCT03153423
Lead sponsor
Minia University
Responsible party
Mohamed Farag Khalil Ibrahiem (Lecturer of ophthalmology, Minia University) — Principal investigator
First posted
May 15, 2017
Start date
Aug 5, 2017
Primary completion
Dec 20, 2019
Completion
Jan 14, 2020
Last update
Feb 20, 2020

Study contacts

Mohamed F Ibrahiem, MD
principal investigator · Minia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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