Trial | NCT00865540  Report issue

Title

Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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 Started
Mar 31
2009
Primary Completion
Aug 31
2011
Anticipated
Study Completion
Aug 31
2011
Anticipated
Last Update
May 24
2011
Estimate

Drug prednisolone acetate 1%

1 drop every 8h two days before surgery

Drug ketorolac tromethamine 0.4%

1 drop every 8h two days before surgery

Drug nepafenac 0.1%

1 drop every 8h two days before surgery

Drug methylcellulose 0.5%

1 drop every 8h two days before surgery

prednisolone acetate 1% Experimental

one drop every 8h two days before surgery

ketorolac tromethamine 0.4% Experimental

one drop every 8h two days before surgery

nepafenac 0.1% Experimental

one drop every 8h two days before surgery

placebo Placebo Comparator

one drop every 8h two days before surgery

Criteria 

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)
No Results Posted