Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323982
• Other study ID #: CCPMOH2020-China-1
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: March 25, 2021

Study information

• Verified date: June 2020
• Source: Sun Yat-sen University
• Contact: Wang Qiwei, MD
• Phone: +86-13924025677
• Email: wang_qiwei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

Procedure:
• new surgical procedure
(ACCC + I / A + PCCC + TA+ A-vit) or (ACCC + I / A + PCCC + IOL + TA + A-vit)
• traditional surgical procedure
(ACCC + I / A + PCCC + A-vit) or (ACCC + I / A + PCCC + IOL + A-vit)

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of high intraocular pressure	Determined with the Tono-pen.	5 years
Primary	incidence of visual axis opacification	Visual axis obscuration will be evaluated based on the retroillumination.	5 years
Primary	incidence of uveitis and iris/pupil abnormality	Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.	5 years
Secondary	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
Secondary	Central corneal thickness	Determined with the pentacam.	5 years
Secondary	Central macular thickness	Determined with the optical coherence tomography.	5 years

External Links

•   Homepage of Zhongshan Ophthalmic Center