NCT04323982

Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 3 Months – 13 Years
• Healthy volunteers: Not accepted

Summary

Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.

Detailed description

Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery. In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups

Conditions

• Congenital Cataract

Interventions

Type	Name	Description
PROCEDURE	new surgical procedure	（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）
PROCEDURE	traditional surgical procedure	（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）

Timeline

• Start date: 2020-03-27
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2020-03-27
• Last updated: 2020-06-04

Locations

1 site across 1 country: China