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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called MIMS® (Minimally Invasive Micro Sclerostomy) for treating primary open angle glaucoma, a condition where high eye pressure can cause vision loss. The researchers aim to determine if MIMS® is as effective as the traditional surgery, trabeculectomy, in managing eye pressure when medications are insufficient. Participants will undergo the MIMS® procedure and be monitored for a year to assess its effectiveness. Suitable candidates have uncontrolled primary open angle glaucoma with eye pressure between 21 and 40 mmHg, despite using multiple medications. As an unphased trial, this study offers the chance to contribute to innovative research that could lead to new treatment options for glaucoma patients.

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 prior data suggests that the MIMS® device/procedure is safe for glaucoma patients?

Research shows that the MIMS® procedure is generally safe. Studies have found it causes minimal harm. The procedure is quick and allows for a fast recovery. No device failures or serious side effects have been reported. However, some patients experienced a blockage at the surgery site and temporary increases in eye pressure. Overall, it appears to be a well-tolerated option for people with glaucoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for glaucoma, like eye drops and laser therapies, aim to reduce eye pressure, but often require ongoing management and frequent doctor visits. The MIMS® Device is unique because it offers a minimally invasive surgical option that creates a small, controlled drainage channel in the eye to relieve pressure. This direct approach potentially reduces the need for continuous medication and lowers the risk of complications associated with more invasive surgeries. Researchers are excited about this treatment because it promises a safer, less intrusive alternative with long-lasting results for glaucoma patients.

What evidence suggests that the MIMS® device is effective for glaucoma?

Research has shown that the Minimally Invasive Micro Sclerostomy (MIMS®) procedure, which participants in this trial will undergo, works well for individuals with mild to moderate uncontrolled open-angle glaucoma. Studies have found that it can help reduce eye pressure in these patients. The MIMS® procedure is designed to be safer and less invasive than traditional glaucoma surgeries. Early results suggest it can be as effective as traditional methods, such as trabeculectomy with Mitomycin-C, in controlling eye pressure. This offers a promising option for those whose glaucoma isn't well-managed with medication alone. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38494493/

Minimally invasive micro sclerostomy (MIMS) procedure in ... Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. Trial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06213805

NCT06213805 | Efficacy and Safety of Minimally Invasive ... The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10946156/

Minimally invasive micro sclerostomy (MIMS) procedure in the ... To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06313749?term=AREA%5BBasicSearch%5D(Glaucoma%201,%20Primary%20Open%20Angle,%20C)&rank=3

Safety and Effectiveness of Minimally Invasive Micro ... Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to ...

5. cureus.com cureus.com/articles/385047-clinical-outcomes-and-patient-reported-outcomes-of-minimally-invasive-glaucoma-surgery-techniques-over-the-past-decade

Clinical Outcomes and Patient-Reported ... Minimally invasive glaucoma surgery (MIGS) has revolutionized glaucoma management over the past decade by offering safer, more efficient ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04503590

Minimally Invasive Micro Sclerostomy: Performance and ... Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will ...

7. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03384-y

Minimally invasive micro sclerostomy (MIMS) procedure in the ... Good results with minimal trauma have been reported, in addition to a high safety profile, relatively short operating time, and quick patient ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06313749/safety-and-effectiveness-of-minimally-invasive-micro-sclerostomy-mimsr-to-reduce-intraocular-pressure-in-open-angle-glaucoma-which-is-not-controlled-despite-polypharmacy?id=1054&slug=open-angle-glaucoma

Safety and Effectiveness of Minimally Invasive Micro ... 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 ...

9. glaucomatoday.com glaucomatoday.com/articles/2022-sept-oct/minimally-invasive-micro-sclerostomy

Minimally Invasive Micro Sclerostomy No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early IOP spikes ...