NCT02158325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

June 4, 2014

Last Update Submit

June 6, 2014

Conditions

Congenital Cataract

Outcome Measures

Primary Outcomes (1)

  • Mean area of anterior/posterior capsulorhexis opening

    two years

Secondary Outcomes (2)

  • the ratio of opacity accounting for posterior capsulorhexis opening at different visits

    two years

  • The area change of anterior/posterior capsulorhexis opening

    two years

Study Arms (3)

3.0-3.9 mm

ACTIVE COMPARATOR

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

Procedure: anterior capsulorhexis sizes

4.0-5.0 mm

EXPERIMENTAL

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

Procedure: anterior capsulorhexis sizes

5.1-6.0 mm

ACTIVE COMPARATOR

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

Procedure: anterior capsulorhexis sizes

Interventions

anterior capsulorhexis sizesPROCEDURE

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

3.0-3.9 mm4.0-5.0 mm5.1-6.0 mm

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

  • 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.

    PMID: 23638058BACKGROUND

  • 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.

    PMID: 23922832BACKGROUND

  • 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.

    PMID: 22921386BACKGROUND

Related Links

Study Officials

  • Haotian Lin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yizhi Liu

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 9, 2014

Record last verified: 2014-06

Locations

CN(1)