RECRUITING

Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

Description

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.

Conditions

Primary Open Angle GlaucomaOpen Angle Glaucoma
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Related Conditions:

Primary Open Angle GlaucomaOpen Angle Glaucoma

Study Overview

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Study Details

Study overview

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.

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

Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

Condition
Primary Open Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Dallas

Glaucoma Associates of Texas, Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanoculis Ltd,

Study Record Dates

2025-12