Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Sun Yat-sen University

Status: Unknown

Conditions: Congenital Cataract

Treatments: Procedure: minimal invasive lens surgery; Procedure: traditional cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03908359

CCPMOH2018-China11

Details and patient eligibility

About

Previously, the investigators have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.

Full description

Patients with congenital cataract that requires surgical intervention are enrolled.

Then the participants are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 1 month and 24 months
• Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
• Informed consent signed by a parent or legal guardian

Exclusion criteria

• confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
• Intraocular pressure >21 mmHg
• Preterm birth (<28 weeks)
• Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
• History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
• History of ocular trauma
• Microcornea
• Persistent hyperplastic primary vitreous
• Rubella
• Lowe syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

traditional cataract surgery

Active Comparator group

Description:

Central anterior continuous capsulorhexis opening (5-6 mm)+ lens irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit)

Treatment:

Procedure: traditional cataract surgery

minimal invasive lens surgery

Experimental group

Description:

Peripheral capsulorhexis opening (1.0-1.5 mm)+lens irrigation/aspiration

Treatment:

Procedure: minimal invasive lens surgery