- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05223153
OCT-A and Amblyopia
October 31, 2022 updated by: Sahar T A Abdelaziz, Minia University
Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minya, Egypt, 61111
- Faculty of Medicine- Minia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with unilateral anisometropic amblyopia without previous treatment with glasses or patches
Description
Inclusion Criteria:
- Unilateral anisometropia.
- Refractive error less than -6.00 D and +4.00 D.
- Age less than 12 years.
- No previous amblyopia treatments
Exclusion Criteria:
1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Amblyopic eye group
|
Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
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Sound eye group
|
Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in retinal vessel density
Time Frame: 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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 15, 2021
Primary Completion (ACTUAL)
August 1, 2022
Study Completion (ACTUAL)
September 30, 2022
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (ACTUAL)
February 3, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ophthalomlogy department
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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