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OCTA Analysis In Children After Lensectomy

Primary Purpose

Deprivation Amblyopia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Optical Coherence Tomography Angiography
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Deprivation Amblyopia

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children after cataract surgery and healthy volunteers

Exclusion Criteria:

  • 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)

Sites / Locations

  • Eye Hospital of WMURecruiting
  • The affiliated Eye Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eyes post-lensectomy

Healthy Eyes

Arm Description

Eyes of children after cataract surgery

Eyes of healthy volunteers

Outcomes

Primary Outcome Measures

Foveal retinal thickness
Foveal retinal thickness in microns
Area of foveal avascular zone
Area of foveal avascular zone in square microns

Secondary Outcome Measures

Full Information

First Posted
December 29, 2019
Last Updated
January 2, 2020
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04217772
Brief Title
OCTA Analysis In Children After Lensectomy
Official Title
Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deprivation Amblyopia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eyes post-lensectomy
Arm Type
Experimental
Arm Description
Eyes of children after cataract surgery
Arm Title
Healthy Eyes
Arm Type
No Intervention
Arm Description
Eyes of healthy volunteers
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography Angiography
Intervention Description
A device testing the vascular density in the retina
Primary Outcome Measure Information:
Title
Foveal retinal thickness
Description
Foveal retinal thickness in microns
Time Frame
up to 36 months
Title
Area of foveal avascular zone
Description
Area of foveal avascular zone in square microns
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children after cataract surgery and healthy volunteers Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangliang Li, MD
Phone
+8613968832833
Email
lizhangliang0328@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yune Zhao, MD
Organizational Affiliation
Eye Hospital of WMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital of WMU
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yune Zhao
Phone
+8613968832833
Email
zyehzeye@126.com
Facility Name
The affiliated Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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OCTA Analysis In Children After Lensectomy

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