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Trial Comparing Ketorolac Tromethamine 0.4% & Prednisolone Acetate 1% in Reducing Post-SLT Anterior Chamber Flare & Cells

Primary Purpose

Postoperative Complications, Inflammation, Glaucoma, Open-Angle

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Postoperative Complications focused on measuring glaucoma, Post operative from selective laser trabeculoplasty

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with open angle glaucoma at the University of Pittsburgh Medical Center (UPMC) Glaucoma Clinic.
  • Able to provide written informed consent to participate.
  • Must be between the ages of 18 - 95.
  • Patients in which further IOP lowering by SLT is necessary in the opinion of the treating physician.

Exclusion Criteria:

  • Patients with eye surgery in the prior six months.
  • Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
  • Patients with pre-existing anterior chamber inflammation.
  • Patients with known sensitivity to any of the study medications.
  • Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study.

Sites / Locations

  • University of Pittsburgh (UPMC Eye Center)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 11, 2006
Last Updated
August 8, 2016
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00410267
Brief Title
Trial Comparing Ketorolac Tromethamine 0.4% & Prednisolone Acetate 1% in Reducing Post-SLT Anterior Chamber Flare & Cells
Official Title
A Randomized Prospective Double - Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-Selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Study Type
Observational

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma. After SLT, many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye (the part in front of the colored part of the eye). This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma. Topical (applied to the surface) corticosteroids can cause an increase in the pressure of the eye (intraocular pressure or IOP), cataract formation, or a possible increase in infection with long-term use. These side effects have not been reported to occur with NSAIDs, which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation, swelling, tenderness, and soreness. This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation after surgery.
Detailed Description
Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma. After SLT, many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye (the part in front of the colored part of the eye). This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma. Topical (applied to the surface) corticosteroids can cause an increase in the pressure of the eye (intraocular pressure or IOP), cataract formation, or a possible increase in infection with long-term use. These side effects have not been reported to occur with NSAIDs, which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation, swelling, tenderness, and soreness. This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation after surgery. To date, there is no study that proves that any one of the three study medications is better than the others for care after SLT. We plan to compare the effect of these anti-inflammatory drops in participants after selective laser trabeculoplasty to see if one works better at helping lower the pressure inside the eye after SLT or whether participants would do just as well with non-medicated eye drops. We will also see how well these drops reduce any potential discomfort and swelling that arise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Inflammation, Glaucoma, Open-Angle
Keywords
glaucoma, Post operative from selective laser trabeculoplasty

7. Study Design

Enrollment
1 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with open angle glaucoma at the University of Pittsburgh Medical Center (UPMC) Glaucoma Clinic. Able to provide written informed consent to participate. Must be between the ages of 18 - 95. Patients in which further IOP lowering by SLT is necessary in the opinion of the treating physician. Exclusion Criteria: Patients with eye surgery in the prior six months. Patients with prior or current use of topical or systemic corticosteroids or NSAIDs. Patients with pre-existing anterior chamber inflammation. Patients with known sensitivity to any of the study medications. Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Noecker, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel S Schuman, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pittsburgh (UPMC Eye Center)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial Comparing Ketorolac Tromethamine 0.4% & Prednisolone Acetate 1% in Reducing Post-SLT Anterior Chamber Flare & Cells

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