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

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: new surgical procedure; Procedure: traditional surgical procedure

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Qiwei Wang, M.D., Ph.D; Phone Number: + 86-13924025677; Email: wang_qiwei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Chair: Chen Weirong, MD, SunYat-sen University

Publications and helpful links

Helpful Links

• Homepage of Zhongshan Ophthalmic Center

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): March 25, 2021
• Study Completion (Anticipated): March 25, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: congenital cataract, Triamcinolone
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2020-China-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No