Capsulorhexis Size and Capsular Outcome

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Congenital Cataract

Intervention / Treatment
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* Procedure: anterior capsulorhexis sizes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3.0-3.9 mm<br>pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0-3.9 mm in diameter) | Procedure: anterior capsulorhexis sizes<br>* Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0 3.9, 4.0 5.0, 5.1 6.0 mm in diameter)<br>|
| Experimental: 4.0-5.0 mm<br>pediatric cataract surgery performed with different anterior capsulorhexis sizes (4.0-5.0 mm in diameter) | Procedure: anterior capsulorhexis sizes<br>* Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0 3.9, 4.0 5.0, 5.1 6.0 mm in diameter)<br>|
| Active Comparator: 5.1-6.0 mm<br>pediatric cataract surgery performed with different anterior capsulorhexis sizes (5.1-6.0 mm in diameter) | Procedure: anterior capsulorhexis sizes<br>* Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0 3.9, 4.0 5.0, 5.1 6.0 mm in diameter)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area of anterior/posterior capsulorhexis opening |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |