NCT06312865

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Status
not yet recruiting

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

March 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

March 9, 2024

Last Update Submit

March 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The difference in demographic criteria in Egyptian population

    6 months

Study Arms (1)

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).

Device: Ophthalmic exam

Interventions

include best corrected visual acuity and cycloplegic refraction data

study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian population

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 15, 2024

Study Start

May 1, 2024

Primary Completion

July 1, 2025

Study Completion

November 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03