Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open Angle Glaucoma
Intervention: Acular LS (Drug); Pred Forte (Drug); Refresh Tears (Other)
Phase: N/A
Status: Completed
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s):
Malik Y. Kahook, MD, Principal Investigator, Affiliation: Rocky Mountain Lions Eye Institute
Summary
We will compare, in a randomized, prospective, masked and controlled fashion the effect of a
nonsteroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a
placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering
and degree of ocular inflammation following selective laser trabeculoplasty treatment for
open angle glaucoma.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Patient Discomfort, Degree of Intraocular Pressure Lowering, and Degree of Ocular Inflammation
Detailed description:
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and
nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the
post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of
compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas
the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid
cascade. Although effective, topical corticosteroids are associated with increase in
intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response
to infection. These adverse side effects have not been reported to occur with topical
NSAIDs, which are effective in controlling the pain after SLT along with the prevention and
suppression of the ocular inflammation. There are ophthalmologists who forgo using the
anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort
the treated eye.
The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred
Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering
following SLT procedure for open angle glaucoma with the hope of resolving the dispute over
the effective post-operative care in SLT patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye
Institute Glaucoma Clinic.
- Able to provide written informed consent to participate.
- Must be the age of 18 years of age or older.
- 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
Locations and Contacts
University of Colorado Eye Center, Aurora, Colorado 80045, United States
Additional Information
Starting date: May 2007
Last updated: July 8, 2015
|
