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Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Primary Purpose

Acute Pseudophakic Cystoid Macular Edema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bromfenac
Ketorolac
Diclofenac
Sponsored by
Bp Consulting, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pseudophakic Cystoid Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
  • Males and females 18 years and older
  • Able to provide written informed consent

Exclusion Criteria:

  • Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
  • Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
  • History of Uveitis
  • Ipsilateral intraocular surgery prior to cataract surgery
  • CME greater than one year duration

Sites / Locations

  • Soll Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Acute Pseudophakic Cystoid Macular Edema

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
January 7, 2008
Last Updated
March 17, 2009
Sponsor
Bp Consulting, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00595543
Brief Title
Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bp Consulting, Inc

4. Oversight

5. Study Description

Brief Summary
To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pseudophakic Cystoid Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bromfenac
Intervention Description
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Primary Outcome Measure Information:
Title
Acute Pseudophakic Cystoid Macular Edema
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery Males and females 18 years and older Able to provide written informed consent Exclusion Criteria: Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker History of Uveitis Ipsilateral intraocular surgery prior to cataract surgery CME greater than one year duration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rho, MD
Organizational Affiliation
Soll Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soll Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

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