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



Status:Terminated
Conditions:Hospital, Ocular
Therapuetic Areas:Ophthalmology, Other
Healthy:No
Age Range:18 - 95
Updated:8/10/2016
Start Date:February 2006
End Date:December 2007

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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

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.

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.

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.
We found this trial at
1
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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