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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


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 obscuration

Intraocular pressure


Minimum age: 6 Weeks. Maximum age: 2 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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