A Phase 4 interventional study of prednisolone acetate 1% and ketorolac tromethamine 0.4% in Cataract, sponsored by Clinica Oftamologica Zona Sul. Status unknown at 1 site in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-05-24.
Sponsored by Clinica Oftamologica Zona Sul · Phase 4, Interventional, and Treatment
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).
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 30 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Clinica Oftamologica Zona Sul is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
one drop every 8h two days before surgery
Drug: prednisolone acetate 1%
one drop every 8h two days before surgery
Drug: ketorolac tromethamine 0.4%
one drop every 8h two days before surgery
Drug: nepafenac 0.1%
one drop every 8h two days before surgery
Drug: methylcellulose 0.5%
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
pupil size
Time frame: 1 day
The record gives a start of Mar 2009, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prednisolone acetate · Ketorolac Tromethamine · Nepafenac
Clinica Oftamologica Zona Sul