Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
1 other identifier
observational
30
1 country
1
Brief Summary
Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. And through the clinical parameters of postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), IOL position and whether appear visual axis opacity to compare the outcome of the 2 IOL implantation methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2021
1 active site
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
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 19, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 11, 2022
March 1, 2022
8 months
February 19, 2022
March 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
IOL position
The horizontal and vertical inclination of IOL
through study completion, an average of 1 year
BCVA
best corrected visual acuity
through study completion, an average of 1 year
Study Arms (2)
optic capture group
IOL optic was captured through the posterior continuous curvilinear capsulorhexis
endocapsular group
IOL was placed in the bag
Interventions
primary or secondary intraocular lens implantation surgery
Eligibility Criteria
Children with congenital cataracts who underwent primary or secondary intraocular lens implantation surgery at the Eye Hospital Affiliated to Wenzhou Medical University.
You may qualify if:
- Children aged 1 to 10 years diagnosed with congenital cataract
- underwent I / II IOL implantation in our hospital
- corneal diameter more than 9mm
- Good compliance
You may not qualify if:
- Patients with other ocular or systemic diseases
- patients whose IOL cannot be implanted in or after the capsule due to ocular conditions
- Children with a history of other ocular surgery
- Low compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Eye Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
February 19, 2022
First Posted
March 11, 2022
Study Start
November 1, 2021
Primary Completion
June 30, 2022
Study Completion
December 31, 2022
Last Updated
March 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share