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

Tracking Information

First Received Date ^ICMJE

February 7, 2012

Last Updated Date

November 25, 2012

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

cystoid macular edema [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Angiography (Miyake's criteria)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01542190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Best corrected visual acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]

ETDRS.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cystoid Macular Edema Following Cataract Surgery, Bilateral

Intervention ^ICMJE

Drug: Ketorolac Tromethamine

ketorolac tromethamine 0.4%

Other Names:

Acular LS (Allergan)
Lacribell (Latinofarma)

Study Arm (s)

Active Comparator: ketorolac tromethamine
Intervention: Drug: Ketorolac Tromethamine
Placebo Comparator: Dextrano 70 / Hypromellose
Intervention: Drug: Ketorolac Tromethamine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rodrigo PC Lira, MD

551935217257

rpclira@fcm.unicamp.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01542190

Other Study ID Numbers ^ICMJE

0018014600011

Has Data Monitoring Committee

Responsible Party

Joao Paulo Felix, University of Campinas, Brazil

Study Sponsor ^ICMJE

University of Campinas, Brazil

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Rodrigo PC Lira

University of Campinas, Brazil

Information Provided By

University of Campinas, Brazil

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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