Cataract Surgery With Intracameral Triamcinolone in Infants
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|ClinicalTrials.gov Identifier: NCT01800708|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : August 14, 2013
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Triamcinolone acetonide Drug: Prednisolone syrup||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2013|
Active Comparator: Triamcinolone acetonide
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Drug: Triamcinolone acetonide
Other Name: Triancinolona Ophthalmos
Active Comparator: Prednisolone syrup
The control group will receive prednisolone syrup postoperatively
Drug: Prednisolone syrup
- Visual axis obscuration [ Time Frame: 1 year after surgery ]Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.
- Intraocular pressure [ Time Frame: 1 year after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800708
|Altino Ventura Foundation|
|Recife, Pernambuco, Brazil, 50070020|
|Principal Investigator:||Marcelo Ventura, MD||Fundação Altino Ventura|