Open Angle Glaucoma
Conditions
Keywords
Intraocular Pressure, MIMS, Inferonasal, Minimally Invasive Glaucoma Surgery, Trabeculectomy, Sclerostomy, MIGS
Brief summary
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).
Interventions
DEVICEInferonasal Minimally Invasive Micro Sclerostomy
The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.
Sponsors
Sanoculis Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Inclusion criteria
1\. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Success Rate (30 months) | 30 months post-MIMS® surgery | Success rate 30 months post-MIMS® surgery |
| Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months) | Medicated baseline to 30 months post-MIMS® surgery | Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery |
| Surgery Success Rate (24 months) | 24 months post-MIMS® surgery | Success rate 24 months post-MIMS® surgery |
| Intraocular Pressure Change (Baseline to 24 months) | Baseline to 24 months post-MIMS® surgery | Change in IOP from medicated baseline to 24 months post-MIMS® surgery |
| Intraocular Pressure Change (Baseline to 30 months) | Baseline to 30 months post-MIMS® surgery | Change in IOP from medicated baseline to 30 months post-MIMS® surgery |
| Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months) | Medicated baseline to 24 months post-MIMS® surgery | Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interventional Safety Outcomes | Baseline to 30 months post-MIMS® surgery | Late (greater than 12 months) postoperative interventions |
| Postoperative Complication Safety Outcomes | Baseline to 30 months post-MIMS® surgery | Late (greater than 12 months) postoperative complications |
Countries
Armenia
Contacts
Primary ContactKhan Lau, OD
Outcome results
None listed