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OCTA Analysis In Children After Lensectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Deprivation Amblyopia Device: Optical Coherence Tomography Angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

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



Primary Outcome Measures :
  1. Foveal retinal thickness [ Time Frame: up to 36 months ]
    Foveal retinal thickness in microns

  2. Area of foveal avascular zone [ Time Frame: up to 36 months ]
    Area of foveal avascular zone in square microns



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217772


Contacts
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Contact: Zhangliang Li, MD +8613968832833 lizhangliang0328@126.com

Locations
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China, Zhejiang
Eye Hospital of WMU Recruiting
Hangzhou, Zhejiang, China, 325027
Contact: Yune Zhao    +8613968832833    zyehzeye@126.com   
The affiliated Eye Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: Yune Zhao, MD Eye Hospital of WMU
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Responsible Party: Yune Zhao, Director of Cataract Department, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04217772    
Other Study ID Numbers: OCTA-LZL
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms