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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02158325
Other study ID # CCPMOH2010-China6
Secondary ID
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


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
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