Capsulorhexis Size and Capsular Outcome

Not Applicable

Completed

• Conditions: Congenital Cataract
• Interventions: Procedure: anterior capsulorhexis sizes

• Registration Number: NCT02158325
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Different capsulorhexis size results in different capsular outcome when treating pediatric cataract, and there should be an appropriate capsulorhexis size for the best capsular outcome.

Detailed Description

Numerous studies have reported that ideal anterior capsulorhexis size is 4.5-5.0 mm with the capsulorhexis edges covering IOL optic surface because it can inhibit the proliferation and migration of remnant lens epithelial cells (LEC). But there are no reports investigating the relationship between the capsulorhexis size and the capsular outcome after pediatric cataract surgery. Therefore, the aim of the current study is to prospective evaluate the capsular outcomes of three controlled groups receiving different anterior capsulorhexis sizes (3.0-3.9, 4.0-5.0, 5.1-6.0 mm in diameter).

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Age< 2 years
• performed cataract surgery without IOL implantation
• without capsular fibrosis, glaucoma, ocular trauma, corneal disorders before surgery
• No other corneal and systemic abnormalities
• Written informed consents provided

Exclusion Criteria

• Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis
• Cases with surgical complications
• those who can't dilute pupil normally postoperation or can't complete the follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3.0-3.9 mm	anterior capsulorhexis sizes	pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0-3.9 mm in diameter)
4.0-5.0 mm	anterior capsulorhexis sizes	pediatric cataract surgery performed with different anterior capsulorhexis sizes (4.0-5.0 mm in diameter)
5.1-6.0 mm	anterior capsulorhexis sizes	pediatric cataract surgery performed with different anterior capsulorhexis sizes (5.1-6.0 mm in diameter)

Primary Outcome Measures

Name	Time	Method
Mean area of anterior/posterior capsulorhexis opening	two years

Secondary Outcome Measures

Name	Time	Method
the ratio of opacity accounting for posterior capsulorhexis opening at different visits	two years
The area change of anterior/posterior capsulorhexis opening	two years

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China