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NCT04077489 Clinical Trial

Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract

Congenital Cataract Clinical Trial

Official title:
To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04077489
Other study ID # WZM2016WDD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date August 1, 2019

Study information
Verified date September 2019
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 1, 2019
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 10 Years
Eligibility Inclusion Criteria:

- congenital cataract

Exclusion Criteria:

-incooperative to complete the preoperative and postoperative examinations.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cataract surgery
To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery

Locations
Country Name City State
China TianTong Beijing

Sponsors (1)
Lead Sponsor Collaborator
yin ying zhao

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary macular thickness macular thickness changes before and after cataract surgery 6 months
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