NCT03908359

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

Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Cataract

Interventions

Type	Name	Description
PROCEDURE	traditional cataract surgery	ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
PROCEDURE	minimal invasive lens surgery	We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2019-04-09
• Last updated: 2022-04-27

Locations

1 site across 1 country: China