OCT-A and Amblyopia

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05223153
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia

Condition or Disease	Intervention/Treatment	Phase
Amblyopia	Diagnostic Test: Optical Coherence tomography angiography

Study Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography
• Actual Study Start Date: Sep 15, 2021
• Actual Primary Completion Date: Jul 1, 2022
• Actual Study Completion Date: Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Amblyopic eye group	Diagnostic Test: Optical Coherence tomography angiography; Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
Sound eye group	Diagnostic Test: Optical Coherence tomography angiography; Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia

Outcome Measures

Primary Outcome Measures

1. Change in retinal vessel density [3 months]

   Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia and effect of treatment on the retinal vessel density

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Unilateral anisometropia.

2. Refractive error less than -6.00 D and +4.00 D.

3. Age less than 12 years.

4. No previous amblyopia treatments

Exclusion Criteria:

1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine- Minia University	Minya		Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sahar T A Abdelaziz, Assistant Professor, Minia University
• ClinicalTrials.gov Identifier: NCT05223153
• Other Study ID Numbers: Ophthalomlogy department
• First Posted: Feb 3, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Aug 8, 2022