This trial is active, not recruiting.

Condition cataract
Treatments prednisolone acetate 1%, ketorolac tromethamine 0.4%, nepafenac 0.1%, methylcellulose 0.5%
Phase phase 4
Sponsor Clinica Oftamologica Zona Sul
Start date March 2009
End date August 2011
Trial size 30 participants
Trial identifier NCT00865540, OMB NO:0925-0586


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
one drop every 8h two days before surgery
prednisolone acetate 1%
1 drop every 8h two days before surgery
one drop every 8h two days before surgery
ketorolac tromethamine 0.4%
1 drop every 8h two days before surgery
one drop every 8h two days before surgery
nepafenac 0.1%
1 drop every 8h two days before surgery
(Placebo Comparator)
one drop every 8h two days before surgery
methylcellulose 0.5%
1 drop every 8h two days before surgery

Primary Outcomes

pupil size
time frame: 1 day

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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)

Additional Information

Official title Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies
Principal investigator Alexandre P Costa, Pinto
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Clinica Oftamologica Zona Sul.