Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Not Applicable

• Conditions: Congenital Cataract
• Interventions: Procedure: traditional surgical procedure; Procedure: new surgical procedure

• Registration Number: NCT04323982
• Lead Sponsor: Sun Yat-sen University

Brief 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

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-26
• Study Start: 2020-03-27
• Study First Posted: 2020-03-27
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age between 3 months and 13 years
2. Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
3. Informed consent signed by a parent or legal guardian

Exclusion Criteria

1. Intraocular pressure >21 mmHg
2. Preterm birth (<28 weeks)
3. Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
4. History of ocular trauma
5. Previous intraocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Cataract Surgery	traditional surgical procedure	For patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit)
New Cataract Surgery	new surgical procedure	Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)

Primary Outcome Measures

Name	Time	Method
incidence of high intraocular pressure	5 years	Determined with the Tono-pen.
incidence of visual axis opacification	5 years	Visual axis obscuration will be evaluated based on the retroillumination.
incidence of uveitis and iris/pupil abnormality	5 years	Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.

Secondary Outcome Measures

Name	Time	Method
Central corneal thickness	5 years	Determined with the pentacam.
Best corrected visual acuity	5 years	Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
Central macular thickness	5 years	Determined with the optical coherence tomography.

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China