Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedAugust 8, 2018
August 1, 2018
1 year
April 10, 2018
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
RNFLT
the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)
1 year
CMT
the macular thickness (CMT) measured by OCT biometry (Units :um)
1 year
Study Arms (1)
the RNFLT and CMT
OTHERthe retinal nerve fiber layer (RNFLT) and macular thickness (CMT)
Interventions
To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
Eligibility Criteria
You may qualify if:
- congenital cataract
You may not qualify if:
- incooperative to complete the preoperative and postoperative examinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027, China
Related Publications (1)
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.
PMID: 27059633BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
April 10, 2018
First Posted
August 8, 2018
Study Start
March 1, 2017
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
August 8, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share