Correction of Anisometropic Amblyopia in Children.

Correction of Anisometropic Amblyopia in Children at School Age.

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

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Amblyopia; Anisometropic Amblyopia; Anisometropia and Aniseikonia
• Intervention / Treatment: Diagnostic test: Axial length measurement in millimeter (mm) by optical biometry device; Diagnostic test: Autorefractometer to measure the refractive error in both eyes.

Detailed Description

Correction of anisometropic amblyopia depends on type of refractive error and axial length of the eye.

In this study, we will asses the types of anisometropia found in children at school age and investigate possible ways for correction of this type of amblyopia.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Ahmed A Tabl, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13511
      • Recruiting
      • Ahmed Abdelshafy Tabl
      • Contact: Ahmed A Tabl; Phone Number: 01222328766; Email: ahmad4lg@gmail.com
      • Sub-Investigator: Marwa Abdelshafy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 device; Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.; Diagnostic test: Autorefractometer to measure the refractive error in both eyes.; Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).
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 device; Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.; Diagnostic test: Autorefractometer to measure the refractive error in both eyes.; Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).
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 device; Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.; Diagnostic test: Autorefractometer to measure the refractive error in both eyes.; Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).
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 device; Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.; Diagnostic test: Autorefractometer to measure the refractive error in both eyes.; Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length of both eyes.	Measurement of axial length of both eyes in millimeter (mm).	Immediately after optical biometry test for each eye.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of refractive errors in anisometropic amblyopia	Type of refractive error found in anisometropia measured by autorefractometer in diopter (D).	Immediately after autorefractometer test for each eye.

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ahmed A Tabl, MD, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: amblyopia; axial refractive error; anisometropia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Refractive Errors; Amblyopia; Aniseikonia; Anisometropia
• Other Study ID Numbers: RC 7-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No