NCT05223153

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

January 24, 2022

Last Update Submit

October 31, 2022

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Change in retinal vessel density

    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

Study Arms (2)

Amblyopic eye group

Diagnostic Test: Optical Coherence tomography angiography

Sound eye group

Diagnostic Test: Optical Coherence tomography angiography

Interventions

Optical Coherence tomography angiographyDIAGNOSTIC_TEST

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

Amblyopic eye groupSound eye group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with unilateral anisometropic amblyopia without previous treatment with glasses or patches

You may qualify if:

  • Unilateral anisometropia.
  • Refractive error less than -6.00 D and +4.00 D.
  • Age less than 12 years.
  • No previous amblyopia treatments

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Minia University

Minya, 61111, Egypt

Location

Related Publications (1)

  • AttaAllah HR, Abdelaziz STA, Mohamed AAM, Ibrahiem MFK. Assessment of macular microvascular changes in children following treatment of anisometropic myopic amblyopia using optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2023 Sep;261(9):2689-2699. doi: 10.1007/s00417-023-06055-8. Epub 2023 Apr 13.

    PMID: 37052667DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 3, 2022

Study Start

September 15, 2021

Primary Completion

August 1, 2022

Study Completion

September 30, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)