Capsulorhexis Size and Capsular Outcome

Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02158325

Enrollment

Registered

2014-06-06

Start date

2011-03-31

Completion date

2012-11-30

Last updated

2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cataract

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).

Interventions

PROCEDUREanterior 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

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

Design outcomes

Primary

Measure	Time frame
Mean area of anterior/posterior capsulorhexis opening	two years

Secondary

Measure	Time frame
the ratio of opacity accounting for posterior capsulorhexis opening at different visits	two years
The area change of anterior/posterior capsulorhexis opening	two years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026