Clinical trial NCT00865540: Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Keywords: cataract
pupillary dilation
anti-inflammatory
therapeutic use
Lead sponsor: Clinica Oftamologica Zona Sul
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: pupil size
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Clínica Oftalmológica Zona Sul
state: Pernambuco
Study officials:
affiliation: Clínica Oftalmológica Zona Sul
name: Alexandre P Costa, Pinto
role: PRINCIPAL_INVESTIGATOR
References: