Clinical trial NCT06313749: Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Open Angle Glaucoma
Open Angle Glaucoma
Keywords: Open Angle Glaucoma
Polypharmacy
Intraocular Pressure
MIMS
Minimally Invasive Glaucoma Surgery
MIGS
MTMT
Lead sponsor: Sanoculis Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 129
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Surgical success rate of the MIMS® device/procedure at 12 months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Exploratory Effectiveness Endpoint 1
timeFrame: 12 months
measure: Exploratory Effectiveness Endpoint 2
timeFrame: 12 months
measure: Exploratory Effectiveness Endpoint 3
timeFrame: 12 months
measure: Exploratory Effectiveness Endpoint 4
timeFrame: 12 months
measure: Safety Outcome 1
timeFrame: 12 months
measure: Safety Outcome 2
timeFrame: 12 months
measure: Safety Outcome 3
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
Study officials:
References: