Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145535
Status:
COMPLETED
Last Update Posted:
2010-01-29
First Post:
2005-09-01
Brief Title:
SOLX Titanium Sapphire Laser for Trabeculoplasty
Sponsor:
SOLX Inc
Organization:
SOLX Inc
Study Overview
Official Title:
SOLX Titanium Sapphire Laser for Trabeculoplasty
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty
Detailed Description:
This is a multi-center outpatient study assessing equivalence of the Titanium Sapphire laser TiSaLT to the Argon laser ALT in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications andor prior failed glaucoma surgery Approximately 120 patients are to be enrolled in the study with approximately equal numbers of patients enrolled at each of the investigational sites The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy andor patients with previously failed laser trabeculoplasty One half of the eyes will be randomized to treatment with the Argon laser ALT as the concurrent control group and the other half will be treated with Titanium Sapphire TiSaLT laser
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