Cataract Surgery With Intracameral Triamcinolone in Infants
Information source: Fundação Altino Ventura
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Triamcinolone acetonide (Drug); Prednisolone syrup (Drug)
Phase: N/A
Status: Completed
Sponsored by: Fundação Altino Ventura Official(s) and/or principal investigator(s): Marcelo Ventura, MD, Principal Investigator, Affiliation: Fundação Altino Ventura
Summary
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.
Clinical Details
Official title: The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Visual axis obscurationIntraocular pressure
Eligibility
Minimum age: 6 Weeks.
Maximum age: 2 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients younger than 2 years of age
- Unilateral or bilateral congenital cataracts compromising the red reflex
Exclusion Criteria:
- Corneal opacity
- 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
Locations and Contacts
Altino Ventura Foundation, Recife, Pernambuco 50070020, Brazil
Additional Information
Starting date: January 2010
Last updated: August 13, 2013
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