Text Size

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

This study is currently recruiting participants.
Verified November 2012 by University of Campinas, Brazil
Sponsor:
Information provided by (Responsible Party):
Joao Paulo Felix, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01542190
First received: February 7, 2012
Last updated: November 25, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Cystoid Macular Edema Following Cataract Surgery, Bilateral
 Drug: Ketorolac Tromethamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • cystoid macular edema [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Angiography (Miyake's criteria)


Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    ETDRS.


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542190

Contacts
Contact: Rodrigo PC Lira, MD 551935217257 rpclira@fcm.unicamp.br

Locations
Brazil
Unicamp Not yet recruiting
Campinas, Sao Paulo, Brazil
Contact: Rodrigo PC Lira, MD     551935217257     rpclira@fcm.unicamp.br    
Contact: Flavia G Ticly, MD     551981773499     flaviaticly@yahoo.com.br    
Principal Investigator: Rodrigo PC Lira, MD            
Unicamp Recruiting
Campinas, Sao Paulo, Brazil, 13083970
Contact: Rodrigo PC Lira, MD     551935217257     rpclira@fcm.unicamp.br    
Contact: Flavia G Ticly, MD     551981773499     flaviaticly@yahoo.com.br    
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Chair: Rodrigo PC Lira University of Campinas, Brazil
  More Information

Additional Information:
Estate University of Campinas  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Joao Paulo Felix, Dr., University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01542190     History of Changes
Other Study ID Numbers: 0018014600011
Study First Received: February 7, 2012
Last Updated: November 25, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
cataract surgery
cystoid macular edema
angiography

Additional relevant MeSH terms:
Edema
Macular Edema
Cataract
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Ketorolac Tromethamine
Ketorolac
Cyclooxygenase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013