Capsulorhexis Size and Capsular Outcome

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02158325
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 3
• Duration (Months): 20.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Procedure: anterior capsulorhexis sizes	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3.0-3.9 mm pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0-3.9 mm in diameter)	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)
Experimental: 4.0-5.0 mm pediatric cataract surgery performed with different anterior capsulorhexis sizes (4.0-5.0 mm in diameter)	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)
Active Comparator: 5.1-6.0 mm pediatric cataract surgery performed with different anterior capsulorhexis sizes (5.1-6.0 mm in diameter)	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)

Outcome Measures

Primary Outcome Measures

1. Mean area of anterior/posterior capsulorhexis opening [two years]

Secondary Outcome Measures

1. the ratio of opacity accounting for posterior capsulorhexis opening at different visits [two years]

2. The area change of anterior/posterior capsulorhexis opening [two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center,Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University
• Study Chair: Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Homepage of Zhongshan Ophthalmic Center

Publications

• 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.
• 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.
• 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.

• Responsible Party: Haotian Lin, Ophthalmologist, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02158325
• Other Study ID Numbers: CCPMOH2010-China6
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 9, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jun 9, 2014