Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04323982
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Procedure: new surgical procedure; Procedure: traditional surgical procedure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts
• Actual Study Start Date: Mar 27, 2020
• Anticipated Primary Completion Date: Mar 25, 2021
• Anticipated Study Completion Date: Mar 25, 2021

Arms and Interventions

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）

Outcome Measures

Primary Outcome Measures

1. incidence of high intraocular pressure [5 years]

   Determined with the Tono-pen.

2. incidence of visual axis opacification [5 years]

   Visual axis obscuration will be evaluated based on the retroillumination.

3. 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

1. 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.

2. Central corneal thickness [5 years]

   Determined with the pentacam.

3. Central macular thickness [5 years]

   Determined with the optical coherence tomography.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Study Chair: Chen Weirong, MD, SunYat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Homepage of Zhongshan Ophthalmic Center

Publications

None provided.

• Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04323982
• Other Study ID Numbers: CCPMOH2020-China-1
• First Posted: Mar 27, 2020
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University: congenital cataract, Triamcinolone
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jun 4, 2020