Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Completed

• Conditions: Pediatric Cataract; Capsular Contracture, Implant

• Registration Number: NCT04803097
• Lead Sponsor: Yune Zhao

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2019-06-01
• Study Completion: 2020-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCOA	20.74 ± 7.89 months	A comparison of posterior capsular opening areas at the corresponding time points
VATA	20.74 ± 7.89 months	A comparison of visual axis transparent areas at the corresponding time points

Secondary Outcome Measures

Name	Time	Method
axial length growth	20.74 ± 7.89 months	The growth of axial length at the corresponding time points

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China