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
|
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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 |
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 : | 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: ketorolac tromethamine |
Drug: Ketorolac Tromethamine
ketorolac tromethamine 0.4%
Other Names:
|
Placebo Comparator: Dextrano 70 / Hypromellose |
Drug: Ketorolac Tromethamine
ketorolac tromethamine 0.4%
Other Names:
|
- cystoid macular edema [ Time Frame: 1 month ]Angiography (Miyake's criteria)
- Best corrected visual acuity [ Time Frame: 1 month ]ETDRS.

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Brazil | |
Unicamp | |
Campinas, Sao Paulo, Brazil, 13083970 | |
Unicamp | |
Campinas, Sao Paulo, Brazil |
Study Chair: | Rodrigo PC Lira | University of Campinas, Brazil |
Additional Information:
Publications:
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 |