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

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


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

Drug Information available for: Tromethamine Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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


Brazil
Unicamp
Campinas, Sao Paulo, Brazil, 13083970
Unicamp
Campinas, Sao Paulo, Brazil

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:

Miyake K, Masuda K, Shirato S, Oshika T, Eguchi K, Hoshi H, Majima Y, Kimura W, Hayashi F. Comparison of diclofenac and fluorometholone in preventing cystoid macular edema after small incision cataract surgery: a multicentered prospective trial. Jpn J Ophthalmol. 2000 Jan-Feb;44(1):58-67.

Miyake K, Ibaraki N. Prostaglandins and cystoid macular edema. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S203-18. Review.

Kim A, Stark WJ. Are topical NSAIDs needed for routine cataract surgery? Am J Ophthalmol. 2008 Oct;146(4):483-5. doi: 10.1016/j.ajo.2008.07.027.

Gass JD, Norton EW. Cystoid macular edema and papilledema following cataract extraction. A fluorescein fundoscopic and angiographic study. Arch Ophthalmol. 1966 Nov;76(5):646-61.

Miyake K. Prevention of cystoid macular edema after lens extraction by topical indomethacin (I). A preliminary report. Albrecht Von Graefes Arch Klin Exp Ophthalmol. 1977 Aug 8;203(2):81-8.

Miyake K, Ota I, Miyake G, Numaga J. Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. J Cataract Refract Surg. 2011 Sep;37(9):1581-8. doi: 10.1016/j.jcrs.2011.03.052.

Rossetti L, Chaudhuri J, Dickersin K. Medical prophylaxis and treatment of cystoid macular edema after cataract surgery. The results of a meta-analysis. Ophthalmology. 1998 Mar;105(3):397-405.

Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.


Responsible Party:	Joao Paulo Felix, Dr., University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT01542190 History of Changes
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:


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

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