Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining
NCT ID: NCT04323982
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-03-27
2021-03-25
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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New Cataract Surgery
Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)
new surgical procedure
（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）
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)
traditional surgical procedure
（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）
Interventions
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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）
Eligibility Criteria
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Inclusion Criteria
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
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
3 Months
13 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Clinical Professor
Principal Investigators
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Chen Weirong, MD
Role: STUDY_CHAIR
SunYat-sen University
Locations
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Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Homepage of Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2020-China-1
Identifier Type: -
Identifier Source: org_study_id
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