Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

Sun Yat-sen University

Status: Enrolling

Conditions: Congenital Cataract

Treatments: Procedure: PCCC+A-Vit procedure; Procedure: PCCC procedure without A-vit

Study type: Interventional

Funder types: Other

Identifiers

NCT05136209

CCPMOH2021-China12

Details and patient eligibility

About

Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.

Full description

Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. PCCC+A-Vit procedure includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with bilateral congenital cataracts without other ocular abnormalities
• Gestational age at birth >37 weeks
• No more than 18 years old
• Pupils could dilate normally pre-operation
• Have signed a consent form
• Can be followed

Exclusion criteria

• Intraocular pressure >21 mmHg
• History of ocular trauma and intraocular surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

PCCC procedure without A-vit

Experimental group

Description:

Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL

Treatment:

Procedure: PCCC procedure without A-vit

PCCC+A-Vit procedure

Active Comparator group

Description:

Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit

Treatment:

Procedure: PCCC+A-Vit procedure