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Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies

Information source: Clinica Oftamologica Zona Sul
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: prednisolone acetate 1% (Drug); ketorolac tromethamine 0.4% (Drug); nepafenac 0.1% (Drug); methylcellulose 0.5% (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Clinica Oftamologica Zona Sul

Official(s) and/or principal investigator(s):
Alexandre P Costa, Pinto, Principal Investigator, Affiliation: Clínica Oftalmológica Zona Sul


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: pupil size

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).


Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.


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)

Locations and Contacts

Clínica Oftalmológica Zona Sul, Recife, Pernambuco 51020-031, Brazil
Additional Information

Starting date: March 2009
Last updated: May 23, 2011

Page last updated: August 23, 2015

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