- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06312865
Intermittent Exotropia in Egyptian Population
March 9, 2024 updated by: Mahmoud F. Rateb, Assiut University
Clinical and Demographic Characteristics of Intermittent Exotropia in Egyptian Population
Strabismus is one of the most frequent ocular problems among developmentally normal children.
The prevalence of strabismus varies among different regions, ranging from 0.06% in Japan to 5.65% in China.
Exotropia is reported to be the most prevalent type of deviation in many of these studies.
About 48-92% of the exotropic patients have intermittent exotropia (IXT).
Jenkins reported that the prevalence of exodeviation was higher in countries near the Equator.
Its prevalence is also higher in subequatorial Africa, the Middle East, and East Asia (where there is plenty of sunshine) in comparison to the USA and Central Europe.
Intermittent exotropia is a disorder of binocular eye movement control, where one eye intermittently turns outward.
The outward deviation is greatest and likely occurs at far distances viewing, when the oculomotor convergence effort is weakest, and occurs frequently when the patient is under stress, tired, ill, or in particular test situations.
X(T) can also occur at near as convergence insufficiency.
Study Overview
Study Type
Observational
Enrollment (Estimated)
600
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Egyptian population
Description
Inclusion Criteria:
- patients diagnosed with 8 prism diopters or more exodeviation at distant or near fixation, regardless of age or fusion control (including exophora, intermittent exotropia, and constant exotropia).
Exclusion Criteria:
- patients with congenital ocular anomalies or ocular mayopathies. Patients with limitation of ocular motility resulting in strabismus, including neurologic or paralytic disorders, previous ocular surgical history, including strabismus and visually affecting surgeries, or any conditions affecting the central visual acuity, including anterior segment abnormality, cataracts, retinal diseases, or blepharoptosis (ocular sensory disorders), were excluded. When a patient was suspected to visit multiple institutions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
study group
patients diagnosed with 8 prism diopters or more exodeviation at distant or near fixation, regardless of age or fusion control (including intermittent exotropia, and constant exotropia).
|
include best corrected visual acuity and cycloplegic refraction data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in demographic criteria in Egyptian population
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
March 9, 2024
First Submitted That Met QC Criteria
March 9, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IXTEGYPT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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