Cataract
Conditions
Keywords
cataract, pupillary dilation, anti-inflammatory, therapeutic use
Brief summary
The main objective of this study is to compare the effect of preoperative use of anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine 0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.
Detailed description
Will be conducted with a randomized clinical trial volunteers with indication of extraction in Recife, Brazil. The surgical technique is employed phacoemulsification with implantation of intraocular lens. Digital photos are taken of the eye at the beginning and end of surgery and with them will be digitally determined the relationship between the corneal area and pupillary area. Each volunteer will be drawn to one of four groups of study (group 1, prednisolone acetate 1%, group 2, of ketorolac tromethamine 0.4%, 0.1% nepafenac group 3 and group 4, placebo). For the volunteers randomly selected for each group will be prescribed medication in its presentation as eye drops (Prednisolone acetate 1%, Pred Fort ®, Allergan ®; of ketorolac tromethamine 0.4%, incite l ®, Allergan ®; Nepafenac 0.1%, Nevanac ® Alcon ® and 0.5% methylcellulose, Fresh Tears ®, Allergan ®), 01 drop every 8 hours for 48 hours before surgery. For all volunteers will also be prescribed gatifloxacin (Zymar ®), 01 drop every 8 hours starting 48 hours before surgery. Was scheduled a minimum sample of 60 volunteers (15 per group).
Interventions
1 drop every 8h two days before surgery
1 drop every 8h two days before surgery
1 drop every 8h two days before surgery
1 drop every 8h two days before surgery
Sponsors
Study design
Eligibility
Inclusion criteria
* Carriers of senile cataract (\> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia
Exclusion criteria
* Diabetic * Using systemic anti-hormonal and non-hormonal * Using topical ocular medication (including anti-glaucomatous) * Individuals with congenital ocular abnormalities and cases in which there is intra-operative complications (hernia or trauma in the iris, posterior capsule rupture or zônula and prolonged phacoemulsification time of ≥ 1 minute). * Volunteers with incipient nuclear cataract (density 1) or advanced (density 4) by the LOCS II classification (density of nuclear cataract ranked 1 to 4 (Chalk et al, 1989)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pupil size | 1 day |
Countries
Brazil