Cataract Surgery With Intracameral Triamcinolone in Infants

Fundação Altino Ventura60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Triamcinolone acetonideDRUG

Prednisolone syrupDRUG

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 2 Years

Medical Language ↔ Plain English

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 (1)

Altino Ventura Foundation

Recife, Pernambuco, Brazil

Outcomes

Primary Outcomes

Visual axis obscuration

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.

Time frame: 1 year after surgery

Intraocular pressure

Time frame: 1 year after surgery

Data from ClinicalTrials.gov

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