Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Mean area of anterior/posterior capsulorhexis opening
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mean area of anterior/posterior capsulorhexis opening
Time Frame: two years
Secondary Outcomes
- the ratio of opacity accounting for posterior capsulorhexis opening at different visits(two years)
- The area change of anterior/posterior capsulorhexis opening(two years)
Investigators
Haotian Lin
Ophthalmologist
Sun Yat-sen University