Open Angle Glaucoma, Primary Open Angle Glaucoma
Conditions
Keywords
Open Angle Glaucoma, Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT
Brief summary
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure 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.
Interventions
DEVICEMinimally Invasive Micro Sclerostomy Device
During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.
Sponsors
Sanoculis Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This clinical study is observer masked only when measuring intraocular pressure (using Goldmann Applanation Tonometry). Intraocular pressure measurements will be determined using the 2-person method to reduce bias. Observer 1 (masked to real time reading) will look through the slit lamp and turn the Goldmann Tonometer dial, and Observer 2 will read and record the intraocular pressure readings. Observer 1 will be unable to see the readings with the use of a masking card.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, ≥ 40 years to ≤ 85 years old 2. Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy 3. Primary open angle glaucoma diagnosis based on: 1. Visual field mean deviation of -3dB or worse and 2. Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos 4. Presence of healthy, free, and mobile conjunctiva in the target quadrant 5. Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\]) 6. Subject is able and willing to attend all scheduled follow-up exams 7. Subject understands and signs the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success rate of the MIMS® device/procedure at 12 months after surgery | 12 months | Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: 1. Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND 2. Using the same number or fewer topical IOP lowering medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Effectiveness Endpoint 2 | 12 months | Change in IOP (% change) from baseline to 12 months follow-up |
| Exploratory Effectiveness Endpoint 3 | 12 months | Change in the number of IOP lowering topical medications from screening to 12 months follow-up |
| Exploratory Effectiveness Endpoint 4 | 12 months | Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up |
| Exploratory Effectiveness Endpoint 1 | 12 months | Change in IOP (mmHg) from baseline to 12 months follow-up |
| Safety Outcome 2 | 12 months | Biomicroscopic slit lamp and ophthalmoscopy findings |
| Safety Outcome 3 | 12 months | Preservation of Best-Corrected Visual Acuity (BCVA) |
| Safety Outcome 1 | 12 months | Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period |
Countries
United States
Contacts
Primary ContactKhan Lau, OD
Outcome results
None listed