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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Drug: prednisolone acetate 1%; Drug: ketorolac tromethamine 0.4%; Drug: nepafenac 0.1%; Drug: methylcellulose 0.5%

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 51020-031
      • Clínica Oftalmológica Zona Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: prednisolone acetate 1%; one drop every 8h two days before surgery	Drug: prednisolone acetate 1%; 1 drop every 8h two days before surgery
EXPERIMENTAL: ketorolac tromethamine 0.4%; one drop every 8h two days before surgery	Drug: ketorolac tromethamine 0.4%; 1 drop every 8h two days before surgery
EXPERIMENTAL: nepafenac 0.1%; one drop every 8h two days before surgery	Drug: nepafenac 0.1%; 1 drop every 8h two days before surgery
PLACEBO_COMPARATOR: placebo; one drop every 8h two days before surgery	Drug: methylcellulose 0.5%; 1 drop every 8h two days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pupil size	1 day

Collaborators and Investigators

• Sponsor: Clinica Oftamologica Zona Sul
• Investigators: Principal Investigator: Alexandre P Costa, Pinto, Clínica Oftalmológica Zona Sul

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ANTICIPATED): August 1, 2011
• Study Completion (ANTICIPATED): August 1, 2011

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (ESTIMATE): March 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 24, 2011
• Last Update Submitted That Met QC Criteria: May 23, 2011
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: anti-inflammatory; cataract; therapeutic use; pupillary dilation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Pupil Disorders; Cataract; Mydriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Ketorolac; Ketorolac Tromethamine; Nepafenac
• Other Study ID Numbers: OMB NO:0925-0586