OCTA Analysis In Children After Lensectomy

Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy

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.

Study Overview

• Status: Unknown
• Conditions: Deprivation Amblyopia
• Intervention / Treatment: Device: Optical Coherence Tomography Angiography

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhangliang Li, MD; Phone Number: +8613968832833; Email: lizhangliang0328@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 325027
      • Recruiting
      • Eye Hospital of WMU
      • Contact: Yune Zhao; Phone Number: +8613968832833; Email: zyehzeye@126.com
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • The Affiliated Eye Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eyes post-lensectomy; Eyes of children after cataract surgery	Device: Optical Coherence Tomography Angiography; A device testing the vascular density in the retina
No Intervention: Healthy Eyes; Eyes of healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: Yune Zhao, MD, Eye Hospital of WMU

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: OCTA-LZL

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