Correction of Anisometropic Amblyopia in Children.

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05325021
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 33.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amblyopia; Anisometropic Amblyopia; Anisometropia and Aniseikonia; Refractive Errors	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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Correction of Anisometropic Amblyopia in Children at School Age.
• Actual Study Start Date: Apr 2, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. Axial length of both eyes. [Immediately after optical biometry test for each eye.]

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

Secondary Outcome Measures

1. Incidence of refractive errors in anisometropic amblyopia [Immediately after autorefractometer test for each eye.]

   Type of refractive error found in anisometropia measured by autorefractometer in diopter (D).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdelshafy Tabl	Banhā	Benha	Egypt	13511

Sponsors and Collaborators

• Benha University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
• ClinicalTrials.gov Identifier: NCT05325021
• Other Study ID Numbers: RC 7-22
• First Posted: Apr 13, 2022
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University: amblyopia; axial refractive error; anisometropia
• Additional relevant MeSH terms: Amblyopia; Refractive Errors; Anisometropia; Aniseikonia

Study Results

No Results Posted as of Apr 13, 2022