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

Not Applicable

• Conditions: Congenital Cataract
• Interventions: Procedure: minimal invasive lens surgery; Procedure: traditional cataract surgery

• Registration Number: NCT03908359
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minimal invasive lens surgery	minimal invasive lens surgery	Peripheral capsulorhexis opening (1.0-1.5 mm)+lens irrigation/aspiration
traditional cataract surgery	traditional cataract surgery	Central anterior continuous capsulorhexis opening (5-6 mm)+ lens irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit)

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	up to five years of age	Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U; 🇨🇳 Guangzhou, Guangdong, China