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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: prednisolone acetate 1%
* Drug: ketorolac tromethamine 0.4%
* Drug: nepafenac 0.1%
* Drug: methylcellulose 0.5%


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisolone acetate 1%<br>one drop every 8h two days before surgery | Drug: prednisolone acetate 1%<br>* 1 drop every 8h two days before surgery<br>|
| Experimental: ketorolac tromethamine 0.4%<br>one drop every 8h two days before surgery | Drug: ketorolac tromethamine 0.4%<br>* 1 drop every 8h two days before surgery<br>|
| Experimental: nepafenac 0.1%<br>one drop every 8h two days before surgery | Drug: nepafenac 0.1%<br>* 1 drop every 8h two days before surgery<br>|
| Placebo Comparator: placebo<br>one drop every 8h two days before surgery | Drug: methylcellulose 0.5%<br>* 1 drop every 8h two days before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupil size |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, pupillary dilation, anti-inflammatory, therapeutic use