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NCT Number: NCT02158325

Capsulorhexis Size and Capsular Outcome

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.

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Key information

Conditions

Congenital Cataract

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center,Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior capsulorhexis sizes

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)

Primary outcomes

  1. Mean area of anterior/posterior capsulorhexis opening

    Time frame: two years

Secondary outcomes

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

    Time frame: two years

  2. The area change of anterior/posterior capsulorhexis opening

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2014
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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