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

Phase 4

• Conditions: Cataract
• Interventions: Drug: nepafenac 0.1%; Drug: methylcellulose 0.5%; Drug: prednisolone acetate 1%; Drug: ketorolac tromethamine 0.4%

• Registration Number: NCT00865540
• Lead Sponsor: Clinica Oftamologica Zona Sul

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).

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Submitted: 2011-05-23
• Last Update Posted: 2011-05-24
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nepafenac 0.1%	nepafenac 0.1%	one drop every 8h two days before surgery
placebo	methylcellulose 0.5%	one drop every 8h two days before surgery
prednisolone acetate 1%	prednisolone acetate 1%	one drop every 8h two days before surgery
ketorolac tromethamine 0.4%	ketorolac tromethamine 0.4%	one drop every 8h two days before surgery

Primary Outcome Measures

Name	Time	Method
pupil size	1 day

Trial Locations

Locations (1)

Clínica Oftalmológica Zona Sul; 🇧🇷 Recife, Pernambuco, Brazil