Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Sun Yat-sen University

Status: Unknown

Conditions: Congenital Cataract

Treatments: Procedure: new surgical procedure; Procedure: traditional surgical procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04323982

CCPMOH2020-China-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 3 months to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

New Cataract Surgery

Experimental group

Description:

Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)

Treatment:

Procedure: new surgical procedure

Traditional Cataract Surgery

Active Comparator group

Description:

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)

Treatment:

Procedure: traditional surgical procedure