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

NCT00410267 | Terminated

• 1 other identifier: 0511006
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Inflammation; Glaucoma, Open-Angle

Keywords

glaucoma; Post operative from selective laser trabeculoplasty

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh (UPMC Eye Center)

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Postoperative Complications; Inflammation; Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ocular Hypertension; Eye Diseases

Study Officials

• Robert J Noecker, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Joel S Schuman, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 9, 2016

Record last verified: 2008-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)