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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06312865
Other study ID # IXTEGYPT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date November 2025

Study information

Verified date March 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date November 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Ophthalmic exam
include best corrected visual acuity and cycloplegic refraction data

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in demographic criteria in Egyptian population 6 months
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