Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation
Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT00433225
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Males or females > 50 years old
-
Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
-
Likely to complete all study visits and able to provide informed consent
-
Visual potential of 20/25 or better
Exclusion Criteria:
-
· Prior use of topical ketorolac
-
Known contraindications to any study medication or ingredients
-
Active ocular diseases or uncontrolled systemic disease
-
Active ocular allergies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ophthalmic Consultants of Long Island | Rockville Centre | New York | United States | 11570 |
Sponsors and Collaborators
- Innovative Medical
Investigators
- Principal Investigator: Eric Donnenfeld, Ophthalmic Consultants of Long Island
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00433225
Other Study ID Numbers:
- 5293
First Posted:
Feb 9, 2007
Last Update Posted:
Sep 10, 2007
Last Verified:
Sep 1, 2007