Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining
Keywords
Abstract
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
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 03/24/2020 |
| Estimated Enrollment Submitted: | 03/25/2020 |
| First Posted: | 03/26/2020 |
| Last Update Submitted: | 06/01/2020 |
| Last Update Posted: | 06/03/2020 |
| Actual Study Start Date: | 03/26/2020 |
| Estimated Primary Completion Date: | 03/24/2021 |
| Estimated Study Completion Date: | 03/24/2021 |
Condition or disease
Intervention/treatment
Procedure: New Cataract Surgery
Procedure: Traditional Cataract Surgery
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: New Cataract Surgery Traditional surgery combined triamcinolone staining of the anterior vitreous (TA) | Procedure: New Cataract Surgery （ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit） |
| Active Comparator: Traditional Cataract Surgery 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 Cataract Surgery （ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit） |
Eligibility Criteria
| Ages Eligible for Study | 3 Months To 3 Months |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. incidence of high intraocular pressure [5 years]
2. incidence of visual axis opacification [5 years]
3. incidence of uveitis and iris/pupil abnormality [5 years]
Secondary Outcome Measures
1. Best corrected visual acuity [5 years]
2. Central corneal thickness [5 years]
3. Central macular thickness [5 years]
