Capsulorhexis Size and Capsular Outcome

Sun Yat-sen University

Status: Completed

Conditions: Congenital Cataract

Treatments: Procedure: anterior capsulorhexis sizes

Study type: Interventional

Funder types: Other

Identifiers

NCT02158325

CCPMOH2010-China6

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: Under 2 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 3 patient groups

3.0-3.9 mm

Active Comparator group

Description:

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

Treatment:

Procedure: anterior capsulorhexis sizes

4.0-5.0 mm

Experimental group

Description:

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

Treatment:

Procedure: anterior capsulorhexis sizes

5.1-6.0 mm

Active Comparator group

Description:

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

Treatment:

Procedure: anterior capsulorhexis sizes