OCTA Analysis In Children After Lensectomy

NCT ID: NCT04217772

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-12-01

Brief Summary

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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

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Conditions

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Deprivation Amblyopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Eyes post-lensectomy

Eyes of children after cataract surgery

Group Type EXPERIMENTAL

Optical Coherence Tomography Angiography

Intervention Type DEVICE

A device testing the vascular density in the retina

Healthy Eyes

Eyes of healthy volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Optical Coherence Tomography Angiography

A device testing the vascular density in the retina

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Director of Cataract Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yune Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital of WMU

Locations

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Eye Hospital of WMU

Hangzhou, Zhejiang, China

Site Status RECRUITING

The affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhangliang Li, MD

Role: CONTACT

+8613968832833

Facility Contacts

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Yune Zhao

Role: primary

+8613968832833

Other Identifiers

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OCTA-LZL

Identifier Type: -

Identifier Source: org_study_id

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