Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery - Full Text View

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

Drug Information available for: Tromethamine Ketorolac Ketorolac tromethamine

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
Study Completion Date:	August 2013
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 7, 2012
Last Updated:	December 2, 2014
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:


Cataract Macular Edema Lens Diseases Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Ketorolac Tromethamine Ketorolac 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

ClinicalTrials.gov processed this record on September 30, 2016