Cataract
Conditions
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.
Interventions
DRUGTriamcinolone acetonide
DRUGPrednisolone syrup
Sponsors
Fundação Altino Ventura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual axis obscuration | 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 | 1 year after surgery | — |
Countries
Brazil
Outcome results
None listed