The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Prednisolone syrup
- Conditions
- Cataract
- Sponsor
- Fundação Altino Ventura
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual axis obscuration
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients younger than 2 years of age
- •Unilateral or bilateral congenital cataracts compromising the red reflex
Exclusion Criteria
- •Corneal opacity
- •Subluxated cataract
- •Traumatic cataract
- •Complex microphthalmia
- •Persistant hyperplastic primary vitreous
- •Retinal detachment
- •Patients with intraoperative complications, such as IOL implanted in the sulcus
Arms & Interventions
Prednisolone syrup
The control group will receive prednisolone syrup postoperatively
Intervention: Prednisolone syrup
Triamcinolone acetonide
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Intervention: Triamcinolone acetonide
Outcomes
Primary Outcomes
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