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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865540
Recruitment Status : Unknown
Verified March 2009 by Clinica Oftamologica Zona Sul.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2009
Last Update Posted : May 24, 2011
Information provided by:
Clinica Oftamologica Zona Sul

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.

Condition or disease Intervention/treatment Phase
Cataract Drug: prednisolone acetate 1% Drug: ketorolac tromethamine 0.4% Drug: nepafenac 0.1% Drug: methylcellulose 0.5% Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : March 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

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

Primary Outcome Measures :
  1. pupil size [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00865540

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Clínica Oftalmológica Zona Sul
Recife, Pernambuco, Brazil, 51020-031
Sponsors and Collaborators
Clinica Oftamologica Zona Sul
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Principal Investigator: Alexandre P Costa, Pinto Clínica Oftalmológica Zona Sul

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Responsible Party: Alexandre Paashaus da Costa Pinto, Clínica Oftalmológica Zona Sul Identifier: NCT00865540     History of Changes
Other Study ID Numbers: OMB NO:0925-0586
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: March 2009
Keywords provided by Clinica Oftamologica Zona Sul:
pupillary dilation
therapeutic use
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Pupil Disorders
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Ketorolac Tromethamine
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic