Back to resultsEffects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
Primary Purpose
Macular, Congenital Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
About this trial
This is an interventional prevention trial for Macular focused on measuring macular thickness
Eligibility Criteria
Inclusion Criteria:
- congenital cataract
Exclusion Criteria:
-incooperative to complete the preoperative and postoperative examinations.
Sites / Locations
- TianTong
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MT
Arm Description
Macular thickness
Outcomes
Primary Outcome Measures
macular thickness
macular thickness changes before and after cataract surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04077489
Brief Title
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
Official Title
To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yin ying zhao
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular, Congenital Cataract
Keywords
macular thickness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MT
Arm Type
Other
Arm Description
Macular thickness
Intervention Type
Procedure
Intervention Name(s)
cataract surgery
Intervention Description
To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
Primary Outcome Measure Information:
Title
macular thickness
Description
macular thickness changes before and after cataract surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
congenital cataract
Exclusion Criteria:
-incooperative to complete the preoperative and postoperative examinations.
Facility Information:
Facility Name
TianTong
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
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