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Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01542190
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Joao Paulo Felix, University of Campinas, Brazil

Study Description
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Brief Summary:

The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.


Condition or disease Intervention/treatment Phase
Cystoid Macular Edema Following Cataract Surgery, Bilateral Drug: Ketorolac Tromethamine Phase 4

Detailed Description:

Purpose:

To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Methods:

This will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=40) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin will be administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. Other included outcomes will be best corrected visual acuity (BCVA), intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.
Study Start Date : February 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ketorolac tromethamine Drug: Ketorolac Tromethamine
ketorolac tromethamine 0.4%
Other Names:
  • Acular LS (Allergan)
  • Lacribell (Latinofarma)
Placebo Comparator: Dextrano 70 / Hypromellose Drug: Ketorolac Tromethamine
ketorolac tromethamine 0.4%
Other Names:
  • Acular LS (Allergan)
  • Lacribell (Latinofarma)


Outcome Measures
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Primary Outcome Measures :
  1. cystoid macular edema [ Time Frame: 1 month ]
    Angiography (Miyake's criteria)


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 1 month ]
    ETDRS.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery.

Exclusion Criteria:

  • Patients with:

    • Diabetes,
    • Hypertension,
    • uveitis,
    • macular disease,
    • congenital ocular abnormalities,
    • cataract density 0 and 3 by LOCS II,
    • pseudoexfoliation syndrome.

Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01542190


Locations
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Brazil
Unicamp
Campinas, Sao Paulo, Brazil, 13083970
Unicamp
Campinas, Sao Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Study Chair: Rodrigo PC Lira University of Campinas, Brazil
More Information
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Additional Information:

Publications:

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Responsible Party: Joao Paulo Felix, Dr., University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01542190    
Other Study ID Numbers: 0018014600011
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Joao Paulo Felix, University of Campinas, Brazil:
cataract surgery
cystoid macular edema
angiography
Additional relevant MeSH terms:
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Cataract
Macular Edema
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action