Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313749
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-02
Brief Title:
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy MIMS to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Sponsor:
Sanoculis Ltd
Organization:
Sanoculis Ltd
Study Overview
Official Title:
An Observer-Masked Single-Arm Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy MIMS to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to show non-inferiority of the MIMS deviceprocedure with Mitomycin-C in terms of its surgical success rate compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma whose intraocular pressure is not controlled despite polypharmacy
Eligible screened participants will undergo the MIMS procedure and will be followed for a period of 12 months in this single-arm study Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C
Eligible screened participants will undergo the MIMS procedure and will be followed for a period of 12 months in this single-arm study Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None