Recruiting

MIMS®

Sponsor:

Sanoculis Ltd

Code:

NCT06313749

Conditions

Primary Open Angle Glaucoma

Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Minimally Invasive Micro Sclerostomy Device

Study Details

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.

Conditions

Primary Open Angle Glaucoma

Open Angle Glaucoma

Study ID

NCT06313749

Start date

Jun 1, 2024

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

129 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MIMS® Device/Procedure Arm

Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.

Interventions

Minimally 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.

Primary outcome measure

  • Surgical success rate of the MIMS® device/procedure at 12 months after surgery [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Glaucoma Associates of Texas

Recruiting

Dallas, Texas, United States, 75231

Contacts

More Information

Sponsor

Sanoculis Ltd

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Keywords

  • Open Angle Glaucoma
  • Polypharmacy
  • Intraocular Pressure
  • MIMS
  • Minimally Invasive Glaucoma Surgery
  • MIGS
  • MTMT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanoculis Ltd on 2024-08-07.