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Capsulorhexis Size and Capsular Outcome

Primary Purpose

Congenital Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anterior capsulorhexis sizes
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Cataract

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center,Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

3.0-3.9 mm

4.0-5.0 mm

5.1-6.0 mm

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean area of anterior/posterior capsulorhexis opening

Secondary Outcome Measures

the ratio of opacity accounting for posterior capsulorhexis opening at different visits
The area change of anterior/posterior capsulorhexis opening

Full Information

First Posted
June 4, 2014
Last Updated
June 6, 2014
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02158325
Brief Title
Capsulorhexis Size and Capsular Outcome
Official Title
Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.0-3.9 mm
Arm Type
Active Comparator
Arm Description
pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0-3.9 mm in diameter)
Arm Title
4.0-5.0 mm
Arm Type
Experimental
Arm Description
pediatric cataract surgery performed with different anterior capsulorhexis sizes (4.0-5.0 mm in diameter)
Arm Title
5.1-6.0 mm
Arm Type
Active Comparator
Arm Description
pediatric cataract surgery performed with different anterior capsulorhexis sizes (5.1-6.0 mm in diameter)
Intervention Type
Procedure
Intervention Name(s)
anterior capsulorhexis sizes
Intervention Description
Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0~3.9, 4.0~5.0, 5.1~6.0 mm in diameter)
Primary Outcome Measure Information:
Title
Mean area of anterior/posterior capsulorhexis opening
Time Frame
two years
Secondary Outcome Measure Information:
Title
the ratio of opacity accounting for posterior capsulorhexis opening at different visits
Time Frame
two years
Title
The area change of anterior/posterior capsulorhexis opening
Time Frame
two years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yizhi Liu
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23638058
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.
Results Reference
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PubMed Identifier
23922832
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.
Results Reference
background
PubMed Identifier
22921386
Citation
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.
Results Reference
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Links:
URL
http://www.gzzoc.com/
Description
Homepage of Zhongshan Ophthalmic Center

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Capsulorhexis Size and Capsular Outcome

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