OCTA Analysis In Children After Lensectomy
Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
1 other identifier
interventional
100
1 country
2
Brief Summary
The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 3, 2020
January 1, 2020
3 years
December 29, 2019
January 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Foveal retinal thickness
Foveal retinal thickness in microns
up to 36 months
Area of foveal avascular zone
Area of foveal avascular zone in square microns
up to 36 months
Study Arms (2)
Eyes post-lensectomy
EXPERIMENTALEyes of children after cataract surgery
Healthy Eyes
NO INTERVENTIONEyes of healthy volunteers
Interventions
A device testing the vascular density in the retina
Eligibility Criteria
You may qualify if:
- children after cataract surgery and healthy volunteers
You may not qualify if:
- presence of corneal opacity preventing detailed imaging
- nystagmus
- retinal disease,
- persistent fetal vasculature
- intraocular inflammation,
- glaucoma
- vitreoretinal surgery
- premature birth
- neurologic disease
- systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eye Hospital of WMU
Hangzhou, Zhejiang, 325027, China
The affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yune Zhao, MD
Eye Hospital of WMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cataract Department
Study Record Dates
First Submitted
December 29, 2019
First Posted
January 3, 2020
Study Start
December 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
January 3, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share