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Clinical Trials/NCT04803097
NCT04803097
Completed
Not Applicable

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens

Yune Zhao1 site in 1 country62 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Capsular Contracture, Implant
Sponsor
Yune Zhao
Enrollment
62
Locations
1
Primary Endpoint
PCOA
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Lens capsular often changes after pediatric cataract surgery,causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.

Detailed Description

To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
January 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yune Zhao
Responsible Party
Sponsor Investigator
Principal Investigator

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

Eligibility Criteria

Inclusion Criteria

  • Children (age 0.5\~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.

Exclusion Criteria

  • Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.

Outcomes

Primary Outcomes

PCOA

Time Frame: 20.74 ± 7.89 months

A comparison of posterior capsular opening areas at the corresponding time points

VATA

Time Frame: 20.74 ± 7.89 months

A comparison of visual axis transparent areas at the corresponding time points

Secondary Outcomes

  • axial length growth(20.74 ± 7.89 months)

Study Sites (1)

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