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OCTA Analysis In Children After Lensectomy

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ClinicalTrials.gov Identifier: NCT04217772
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE December 29, 2019
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • Foveal retinal thickness [ Time Frame: up to 36 months ]
    Foveal retinal thickness in microns
  • Area of foveal avascular zone [ Time Frame: up to 36 months ]
    Area of foveal avascular zone in square microns
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OCTA Analysis In Children After Lensectomy
Official Title  ICMJE Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Deprivation Amblyopia
Intervention  ICMJE Device: Optical Coherence Tomography Angiography
A device testing the vascular density in the retina
Study Arms  ICMJE
  • Experimental: Eyes post-lensectomy
    Eyes of children after cataract surgery
    Intervention: Device: Optical Coherence Tomography Angiography
  • No Intervention: Healthy Eyes
    Eyes of healthy volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zhangliang Li, MD +8613968832833 lizhangliang0328@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217772
Other Study ID Numbers  ICMJE OCTA-LZL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yune Zhao, Wenzhou Medical University
Study Sponsor  ICMJE Wenzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yune Zhao, MD Eye Hospital of WMU
PRS Account Wenzhou Medical University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP