Cataract Surgery With Intracameral Triamcinolone in Infants
NCT ID: NCT01800708
Last Updated: 2013-08-14
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Triamcinolone acetonide
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Triamcinolone acetonide
Prednisolone syrup
The control group will receive prednisolone syrup postoperatively
Prednisolone syrup
Interventions
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Triamcinolone acetonide
Prednisolone syrup
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unilateral or bilateral congenital cataracts compromising the red reflex
Exclusion Criteria
* Glaucoma
* Aniridia
* Subluxated cataract
* Traumatic cataract
* Complex microphthalmia
* Persistant hyperplastic primary vitreous
* Retinal detachment
* Patients with intraoperative complications, such as IOL implanted in the sulcus
6 Weeks
2 Years
ALL
No
Sponsors
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Fundação Altino Ventura
OTHER
Responsible Party
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Principal Investigators
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Marcelo Ventura, MD
Role: PRINCIPAL_INVESTIGATOR
Fundação Altino Ventura
Locations
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Altino Ventura Foundation
Recife, Pernambuco, Brazil
Countries
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Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id