NCT05325021

Brief Summary

Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 2, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 5, 2022

Last Update Submit

April 5, 2022

Conditions

AmblyopiaAnisometropic AmblyopiaAnisometropia and AniseikoniaRefractive Errors

Keywords

amblyopiaaxial refractive erroranisometropia

Outcome Measures

Primary Outcomes (1)

  • Axial length of both eyes.

    Measurement of axial length of both eyes in millimeter (mm).

    Immediately after optical biometry test for each eye.

Secondary Outcomes (1)

  • Incidence of refractive errors in anisometropic amblyopia

    Immediately after autorefractometer test for each eye.

Study Arms (4)

Axial myopia

children have anisometropia due to axial myopia, axial length will be measured by optical biometry device in millimeter (mm).

Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry deviceDiagnostic Test: Autorefractometer to measure the refractive error in both eyes.

Refractive myopia

children have anisometropia due to refractive myopia, axial length will be measured by optical biometry device in mm.

Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry deviceDiagnostic Test: Autorefractometer to measure the refractive error in both eyes.

Axial hyperopia

children have anisometropia due to axial hyperopia, axial length will be measured by optical biometry device in mm.

Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry deviceDiagnostic Test: Autorefractometer to measure the refractive error in both eyes.

Refractive hyperopia

children have anisometropia due to refractive hyperopia, axial length will be measured by optical biometry device in mm.

Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry deviceDiagnostic Test: Autorefractometer to measure the refractive error in both eyes.

Interventions

Axial length measurement in millimeter (mm) by optical biometry deviceDIAGNOSTIC_TEST

Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.

Axial hyperopiaAxial myopiaRefractive hyperopiaRefractive myopia
Autorefractometer to measure the refractive error in both eyes.DIAGNOSTIC_TEST

Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).

Axial hyperopiaAxial myopiaRefractive hyperopiaRefractive myopia

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Residents of a Banha city that were diagnosed as anisometropic amblyopia and are seeking refractive error corrections.

You may qualify if:

  • Anisometropic amblyopia.
  • Children at school age ranged from 4 to 12 years old.

You may not qualify if:

  • Emmetropia children.
  • Children had undergone any intraocular surgeries.
  • Other types of amblyopia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

AmblyopiaAnisometropiaAniseikoniaRefractive Errors

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Tabl, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 13, 2022

Study Start

April 2, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

EG(1)