MIMS Device for Glaucoma

Overseen By Khan Lau, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanoculis Ltd

Must be taking: Polypharmacy

Disqualifiers: Age, Healthy conjunctiva, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 1 day

129 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since it mentions participants have glaucoma not controlled despite polypharmacy (using multiple medications), it seems likely you may continue your current medications.

What data supports the effectiveness of the MIMS treatment for glaucoma?

Research suggests that the MIMS procedure, which is a type of minimally invasive surgery, shows promise in treating open-angle glaucoma by reducing eye pressure without the need for implants. This approach is part of a broader trend in glaucoma treatments that aim to lower eye pressure with minimal damage and quick recovery. ^{1 2 3 4 5}

Is the MIMS Device for Glaucoma safe for humans?

The MIMS Device, part of minimally invasive glaucoma surgery (MIGS), is generally considered safe with common side effects like temporary bleeding in the eye, pressure spikes, and device movement. However, the quality of safety studies is often low, and more independent research is needed. ^{6 7 8 9 10}

What makes the MIMS treatment unique for glaucoma?

The MIMS treatment for glaucoma is unique because it is a stent-less procedure that involves creating a small opening in the eye to improve fluid drainage, reducing eye pressure without the need for implants. This minimally invasive approach aims for quicker recovery and less tissue damage compared to traditional surgeries. ^{3 4 11 12 13}

Eligibility Criteria

This trial is for men and women aged 40-85 with primary open-angle glaucoma, whose eye pressure isn't controlled despite using multiple medications. Participants must have a certain level of vision loss and be able to attend follow-up exams. They should not have had any recent eye surgeries that affect the conjunctiva.

Inclusion Criteria

I have read and signed the informed consent form.

I am between 40 and 85 years old.

My glaucoma is not well-controlled, with eye pressure between 21 and 40 despite multiple medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the MIMS® procedure with Mitomycin-C

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MIMS® procedure

12 months

Regular visits over 12 months

Treatment Details

Interventions

• Minimally Invasive Micro Sclerostomy (MIMS®)

Trial Overview The study tests the MIMS® device/procedure against traditional trabeculectomy, both using Mitomycin-C, in reducing eye pressure for glaucoma patients over a period of 12 months. The goal is to show that MIMS® is at least as effective as the standard surgery.

Participant Groups

Group I: MIMS® Device/Procedure Arm Experimental Treatment 1 Intervention

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

Minimally Invasive Micro Sclerostomy (MIMS®) is already approved in European Union for the following indications:

Approved in European Union as MIMS for:

• Primary open-angle glaucoma
• Pseudoexfoliative glaucoma
• Pigmentary glaucoma

Who Is Running the Clinical Trial?

Sanoculis Ltd

Lead Sponsor

Trials

9

Recruited

660+

Findings from Research

Microinvasive Glaucoma Surgery (MIGS) provides a safer treatment option for glaucoma, allowing for intervention at earlier stages and reducing reliance on patient compliance with eye drops.

MIGS procedures have demonstrated established efficacy in lowering intraocular pressure through various mechanisms, but further research, including more randomized control trials, is needed to evaluate their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microinvasive Glaucoma Surgery: An Evidence-Based Assessment. Schehlein, EM., Kaleem, MA., Swamy, R., et al.[2022]

Enzymatic sclerostomy effectively reduced intraocular pressure in patients with primary open-angle glaucoma, showing a significant decrease from an average of 43.5 mm Hg preoperatively to 24.8 mm Hg on the first postoperative day and 34.8 mm Hg after one year, without the need for antiglaucoma medications.

The procedure was generally safe, with most adverse effects being mild and localized, although one case of full-thickness perforation occurred, highlighting the need for further technical refinement of the method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzymatic sclerostomy: pilot human study. Dan, JA., Honavar, SG., Belyea, DA., et al.[2019]

The ab interno Minimally Invasive Micro Sclerostomy (MIMS) procedure shows promising efficacy for treating open-angle glaucoma, achieving a significant mean intraocular pressure reduction of 47.4% at 24 weeks post-surgery.

While the procedure is generally safe with no serious adverse events reported, iris clogging at the incision site was a notable complication in 16.12% of patients, indicating a need for careful monitoring post-operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. Geffen, N., Kumar, DA., Barayev, E., et al.[2023]

Minimally invasive glaucoma surgery (MIGS) procedures are designed to lower intraocular pressure with minimal tissue damage, leading to quicker recovery times and simpler surgical techniques.

New glaucoma micro-stents, such as Sclemm's canal stents and Suprachoroidal stents, are being developed to enhance aqueous outflow, offering innovative alternatives to traditional glaucoma drainage implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Era of Glaucoma Micro-stent Surgery. Manasses, DT., Au, L.[2020]

In a study of 18 patients with glaucoma who underwent microincision vitreous surgery (MIVS), intraocular pressure (IOP) showed a gradual increase over time, particularly at the 12-month mark, indicating that IOP control may be a concern post-surgery.

Despite the increase in IOP, the number of antiglaucoma medications used by patients decreased from a median of 1.0 preoperatively to 0 at the final visit, suggesting that MIVS may help reduce the need for medication, although long-term monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Microincision Vitreous Surgery Induces Bleb Failure in Eyes With Functional Filtering Bleb. Oogi, S., Nakakura, S., Asaoka, R., et al.[2022]

Minimally invasive glaucoma surgery (MIGS) devices have been developed to provide safer alternatives to traditional trabeculectomy, with 15 different devices reviewed for their safety and efficacy in treating glaucoma.

While most MIGS devices are reported to be well-tolerated with minimal complications, the CyPass Micro-Stent was withdrawn due to safety concerns, highlighting the need for more rigorous studies to ensure the long-term safety of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices. Rowson, AC., Hogarty, DT., Maher, D., et al.[2022]

Microinvasive glaucoma surgery (MIGS) offers a promising alternative for glaucoma patients looking to reduce medication use and avoid complications from traditional surgery, with varying efficacy and safety profiles among different devices.

Schlemm's canal devices are noted for their excellent safety but provide modest pressure reduction, while subconjunctival and suprachoroidal devices may lower intraocular pressure more effectively but come with a higher risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Microinvasive Glaucoma Surgery. Chen, DZ., Sng, CCA.[2022]

Minimally or Micro-Invasive Glaucoma Surgery (MIGS) shows promise as a safer surgical option for glaucoma treatment, with fewer complications and effective reduction in intraocular pressure and medication use, based on a review of 12 high-quality studies.

However, many studies on MIGS lack control groups and have small sample sizes, highlighting the need for more rigorous, independent research to better inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Studies of Minimally Invasive Glaucoma Surgeries: Systematic Review and Quality Assessment. Rosdahl, JA., Gupta, D.[2020]

Micro-invasive glaucoma surgery (MIGS) techniques are gaining popularity due to their ability to safely and effectively reduce intraocular pressure (IOP) with minimal trauma to the eye, potentially decreasing the need for glaucoma medications.

Various new glaucoma micro-stents, such as Schlemm's canal stents and suprachoroidal stents, have been developed and show promising results in clinical studies for improving aqueous outflow and lowering IOP in patients with glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents. Pillunat, LE., Erb, C., Jünemann, AG., et al.[2022]

Micro-invasive glaucoma surgery (MIGS) offers a safer alternative to traditional glaucoma surgeries, but it still carries unique risks, such as intraoperative malpositioning of microstents that can lead to complications like luminal obstruction and elevated intraocular pressure (IOP).

While some MIGS procedures, like the Xen Gel Stent, have shown higher rates of acute IOP elevation (up to 21.5%), most complications, including hypotony, are transient and resolve with conservative treatment, indicating that MIGS can be a viable option for earlier intervention in glaucoma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of micro-invasive glaucoma surgery. Yook, E., Vinod, K., Panarelli, JF.[2022]

In a study of 247 patients over 24 months, the iStent combined with endoscopic cyclophotocoagulation (ICE2) showed no significant difference in intraocular pressure (IOP) compared to the PreserFlo MicroShunt (PMS) and XEN-45 gel implant, indicating similar effectiveness among these minimally invasive glaucoma surgeries.

The PMS group demonstrated a significant reduction in medication usage over 24 months and had better visual acuity outcomes compared to ICE2, suggesting it may offer additional benefits in managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of iStent combined with phacoemulsification and endocyclophotocoagulation (ICE2) with the PreserFlo MicroShunt and XEN-45 implants. Qidwai, U., Jones, L., Ratnarajan, G.[2022]

The study involving 54 patients showed that combining cataract surgery with the implantation of the iStent significantly reduced intraocular pressure (IOP) from a mean of 17.1 mm Hg to 15.1 mm Hg over an average follow-up of 20 months.

Patients also experienced improved visual acuity, with all eyes achieving a corrected distance visual acuity of 0.5 or better by the end of the observation period, and a substantial reduction in the need for anti-glaucoma medications from an average of 1.7 drops to 0.26.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-term evaluation of the safety and efficacy of the iStent trabecular micro-bypass system combined with phacoemulsification. Kozera, M., Konopińska, J., Rękas, M.[2021]

Minimally invasive glaucoma surgery (MIGS) devices are designed to lower intraocular pressure and improve safety and outcomes for glaucoma patients, addressing the needs of over 70 million people affected by this condition worldwide.

Recent advancements in manufacturing techniques have led to the development of novel implantable MIGS devices, which are among the smallest medical implants, highlighting the importance of design criteria and user requirements for future innovations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Minimally Invasive Glaucoma Surgery Devices. Lee, RMH., Bouremel, Y., Eames, I., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Microinvasive Glaucoma Surgery: An Evidence-Based Assessment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Enzymatic sclerostomy: pilot human study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The New Era of Glaucoma Micro-stent Surgery. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Microincision Vitreous Surgery Induces Bleb Failure in Eyes With Functional Filtering Bleb. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Microinvasive Glaucoma Surgery. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Prospective Studies of Minimally Invasive Glaucoma Surgeries: Systematic Review and Quality Assessment. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Complications of micro-invasive glaucoma surgery. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A comparison of iStent combined with phacoemulsification and endocyclophotocoagulation (ICE2) with the PreserFlo MicroShunt and XEN-45 implants. [2022]

12. Poland pubmed.ncbi.nlm.nih.gov

Mid-term evaluation of the safety and efficacy of the iStent trabecular micro-bypass system combined with phacoemulsification. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Translating Minimally Invasive Glaucoma Surgery Devices. [2021]