Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
Primary Purpose
Congenital Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Cataract focused on measuring RNFLT
Eligibility Criteria
Inclusion Criteria:
- congenital cataract
Exclusion Criteria:
- incooperative to complete the preoperative and postoperative examinations
Sites / Locations
- Eye Hospital of Wenzhou Medical College
- Ophthalmology and Optometry Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
the RNFLT and CMT
Arm Description
the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)
Outcomes
Primary Outcome Measures
RNFLT
the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)
CMT
the macular thickness (CMT) measured by OCT biometry (Units :um)
Secondary Outcome Measures
Full Information
NCT ID
NCT03621579
First Posted
April 10, 2018
Last Updated
August 7, 2018
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03621579
Brief Title
Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
Official Title
Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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 retinal nerve fiber layer. However, there are different opinions about the effect of amblyopia on the optic nerve fiber thickness around the optic disc at home and abroad. 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 retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before and after surgery. Investigators dynamically observed changes in RNFL and CMT to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.
Detailed Description
This prospective study reviewed children with CC who were undergoing cataract extraction with IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. bilateral and unilateral CC children were placed in Study group, while age-matched normal children were included as controls. Children who were uncooperative to complete the preoperative and postoperative examinations were excluded.
All eyes were divided into 4 groups. Group 1: form deprivation amblyopia of unilateral CC, Group 2: unaffected eyes of unilateral CC, Group 3: form deprivation amblyopia of bilateral CC, Group 4: normal eyes of normal children. The preoperative and postoperative data including sex, age at surgery, 7 position of RNFLT and CMT were collected.
All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Investigators used OCT biometry to measure participants' the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before surgery and 1 week, 1 month, 3 months, and 6 months and 1 year after surgery, and compared with age-matched normal children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
RNFLT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the RNFLT and CMT
Arm Type
Other
Arm Description
the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)
Intervention Type
Procedure
Intervention Name(s)
cataract surgery
Intervention Description
To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
Primary Outcome Measure Information:
Title
RNFLT
Description
the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)
Time Frame
1 year
Title
CMT
Description
the macular thickness (CMT) measured by OCT biometry (Units :um)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 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
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Ophthalmology and Optometry Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27059633
Citation
Bansal P, Ram J, Sukhija J, Singh R, Gupta A. Retinal Nerve Fiber Layer and Macular Thickness Measurements in Children After Cataract Surgery Compared With Age-Matched Controls. Am J Ophthalmol. 2016 Jun;166:126-132. doi: 10.1016/j.ajo.2016.03.041. Epub 2016 Apr 5.
Results Reference
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Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
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