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

Sponsor
yin ying zhao (Other)
Overall Status
Completed
CT.gov ID
NCT04077489
Collaborator
(none)
50
1
1
43
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: MT

Macular thickness

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

Outcome Measures

Primary Outcome Measures

  1. macular thickness [6 months]

    macular thickness changes before and after cataract surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • congenital cataract
Exclusion Criteria:

-incooperative to complete the preoperative and postoperative examinations.

Contacts and Locations

Locations

Site City State Country Postal Code
1 TianTong Beijing China

Sponsors and Collaborators

  • yin ying zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
yin ying zhao, Yin Ying Zhao, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04077489
Other Study ID Numbers:
  • WZM2016WDD
First Posted:
Sep 4, 2019
Last Update Posted:
Sep 4, 2019
Last Verified:
Sep 1, 2019
Keywords provided by yin ying zhao, Yin Ying Zhao, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2019