Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478036
Status:
TERMINATED
Last Update Posted:
2016-10-07
First Post:
2007-05-23
Brief Title:
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 04 and Prednisolone Acetate 1 in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Investigators will compare in a randomized prospective masked and controlled fashion the effect of a non-steroidal 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None