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NCT Number: NCT06313749

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

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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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Open Angle Glaucoma

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location status: Recruiting

Location contact

Davinder Grover, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Visual field mean deviation of -3dB or worse and
  • 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
  • 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

Treatment and study plan

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.

Other names: MIMS® Device

Primary outcomes

  1. Surgical success rate of the MIMS® device/procedure at 12 months after surgery

    Time frame: 12 months

    Definition of Surgical Success: the subject's eye, after having the MIMS® procedure:

    • Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND
    • Using the same number or fewer topical IOP lowering medications

Secondary outcomes

  1. Exploratory Effectiveness Endpoint 1

    Time frame: 12 months

    Change in IOP (mmHg) from baseline to 12 months follow-up

  2. Exploratory Effectiveness Endpoint 2

    Time frame: 12 months

    Change in IOP (% change) from baseline to 12 months follow-up

  3. Exploratory Effectiveness Endpoint 3

    Time frame: 12 months

    Change in the number of IOP lowering topical medications from screening to 12 months follow-up

  4. Exploratory Effectiveness Endpoint 4

    Time frame: 12 months

    Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up

  5. Safety Outcome 1

    Time frame: 12 months

    Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period

  6. Safety Outcome 2

    Time frame: 12 months

    Biomicroscopic slit lamp and ophthalmoscopy findings

  7. Safety Outcome 3

    Time frame: 12 months

    Preservation of Best-Corrected Visual Acuity (BCVA)

Study contacts

Contact information is provided by the study sponsor or research team.

Khan Lau, OD

CONTACT

[email protected]

8082862666

Sponsors and collaborators

Lead sponsor

Sanoculis Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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