Cataract Surgery With Intracameral Triamcinolone in Infants

Fundação Altino Ventura

Status: Completed

Conditions: Cataract

Treatments: Drug: Triamcinolone acetonide; Drug: Prednisolone syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT01800708

1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 6 weeks to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Triamcinolone acetonide

Active Comparator group

Description:

The study group will receive an intraoperative intracameral injection of triamcinolone acetonide

Treatment:

Drug: Triamcinolone acetonide

Prednisolone syrup

Active Comparator group

Description:

The control group will receive prednisolone syrup postoperatively

Treatment:

Drug: Prednisolone syrup