Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Congenital Cataract

Intervention / Treatment
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* Procedure: new surgical procedure
* Procedure: traditional surgical procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 3 months and 13 years Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity) Informed consent signed by a parent or legal guardian Exclusion Criteria: Intraocular pressure >21 mmHg Preterm birth (<28 weeks) Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy) History of ocular trauma Previous intraocular surgery

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Cataract Surgery<br>Traditional surgery combined triamcinolone staining of the anterior vitreous (TA) | Procedure: new surgical procedure<br>* （ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）<br>|
| Active Comparator: Traditional Cataract Surgery<br>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) | Procedure: traditional surgical procedure<br>* （ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital cataract, Triamcinolone