Efficacy of Topical Ketorolac Versus Placebo for Improvin... | NCT00433225

Studies
Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation

NCT00433225

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Sep 10, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Macula Thickening

Interventions

Prednisolone Acetate
Ketorolac 0.4%
Gatifloxacin 0.3%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 7, 2007

First Submission Date that Met QC Criteria

Feb 8, 2007

First Posted Date

Feb 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2007

Last Update Posted Date

Sep 10, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Donnenfeld	Ophthalmic Consultants of Long Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Consultants of Long Island		Rockville Centre	New York	11570	United States

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone Acetate	Drug
Ketorolac 0.4%	Drug
Gatifloxacin 0.3%	Drug