Capsulorhexis Size and Capsular Outcome

Congenital Cataract Clinical Trial

Official title:

Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158325
• Other study ID #: CCPMOH2010-China6
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: June 6, 2014
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

Procedure:
• anterior capsulorhexis sizes
Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0~3.9, 4.0~5.0, 5.1~6.0 mm in diameter)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24. — View Citation

Lin H, Chen W, Luo L, Zhang X, Chen J, Lin Z, Qu B, Zhan J, Zheng D, Zhong X, Tian Z, Liu Y; Study Group of CCPMOH. Ocular hypertension after pediatric cataract surgery: baseline characteristics and first-year report. PLoS One. 2013 Jul 29;8(7):e69867. doi: 10.1371/journal.pone.0069867. Print 2013. — View Citation

Luo L, Lin H, Chen W, Wang C, Zhang X, Tang X, Liu J, Congdon N, Chen J, Lin Z, Liu Y. In-the-bag intraocular lens placement via secondary capsulorhexis with radiofrequency diathermy in pediatric aphakic eyes. PLoS One. 2013 Apr 24;8(4):e62381. doi: 10.1371/journal.pone.0062381. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean area of anterior/posterior capsulorhexis opening		two years	No
Secondary	the ratio of opacity accounting for posterior capsulorhexis opening at different visits		two years	No
Secondary	The area change of anterior/posterior capsulorhexis opening		two years	No

External Links

•   Homepage of Zhongshan Ophthalmic Center