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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIMS® Device/Procedure Arm | Experimental | Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Micro Sclerostomy Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate of the MIMS® device/procedure at 12 months after surgery | Definition of Surgical Success: the subject's eye, after having the MIMS® procedure:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Effectiveness Endpoint 1 | Change in IOP (mmHg) from baseline to 12 months follow-up | 12 months |
| Exploratory Effectiveness Endpoint 2 | Change in IOP (% change) from baseline to 12 months follow-up |
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Inclusion Criteria:
Male or female, ≥ 40 years to ≤ 85 years old
Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
Primary open angle glaucoma diagnosis based on:
Presence of healthy, free, and mobile conjunctiva in the target quadrant
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])
Subject is able and willing to attend all scheduled follow-up exams
Subject understands and signs the informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khan Lau, OD | Contact | 8082862666 | khan@sanoculis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaucoma Associates of Texas | Recruiting | Dallas | Texas | 75231 | United States |
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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.
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|
| 12 months |
| Exploratory Effectiveness Endpoint 3 | Change in the number of IOP lowering topical medications from screening to 12 months follow-up | 12 months |
| Exploratory Effectiveness Endpoint 4 | Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up | 12 months |
| Safety Outcome 1 | Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period | 12 months |
| Safety Outcome 2 | Biomicroscopic slit lamp and ophthalmoscopy findings | 12 months |
| Safety Outcome 3 | Preservation of Best-Corrected Visual Acuity (BCVA) | 12 months |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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