Capsulorhexis Size and Capsular Outcome

NCT ID: NCT02158325

Last Updated: 2014-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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).

Conditions

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Congenital Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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3.0-3.9 mm

pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0-3.9 mm in diameter)

Group Type ACTIVE_COMPARATOR

anterior capsulorhexis sizes

Intervention Type PROCEDURE

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

4.0-5.0 mm

pediatric cataract surgery performed with different anterior capsulorhexis sizes (4.0-5.0 mm in diameter)

Group Type EXPERIMENTAL

anterior capsulorhexis sizes

Intervention Type PROCEDURE

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

5.1-6.0 mm

pediatric cataract surgery performed with different anterior capsulorhexis sizes (5.1-6.0 mm in diameter)

Group Type ACTIVE_COMPARATOR

anterior capsulorhexis sizes

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yizhi Liu

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center,Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23638058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23922832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22921386 (View on PubMed)

Related Links

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http://www.gzzoc.com/

Homepage of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2010-China6

Identifier Type: -

Identifier Source: org_study_id

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