GlaucomaNCT04484155
Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study
A study testing Minimally Invasive Micro Sclerostomy (MIMS) in people with Glaucoma, run by Sanoculis Ltd at 1 site in India.
Trial summary
Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Minimally Invasive Micro Sclerostomy (MIMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- 16 Jul 2018to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years
- End stage Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
- Optic nerve appearance characteristic of glaucoma in the study eye
- Best-corrected visual acuity (BCVA) with ETDRS charts ≤ 6/60
- Patient is treated with 0 to 5 hypotensive medications in the study eye
- Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye
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- If cataract is not present - Shaffer grade ≥ III in all four angle quadrants in the study eye
- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
Who cannot join
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL.
- Congenital or developmental glaucoma in either eye
- Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
- Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
- Subject has history of penetrating keratoplasty (PKP)
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- Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.
- Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
- Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
- Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
- Best-corrected visual acuity worse than 20/50 (Snellen equivalent) in the fellow eye
- History of idiopathic or autoimmune uveitis in either eye
- Severe trauma in study eye
- active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil
- Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study eye
- Aphakia
- Prior vitreoretinal surgery in study eye
- Clinically significant ocular inflammation or infection within 90 days prior to screening
- Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
- Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits
- Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Micro Sclerostomy: First in Man (FIM) Safety and Preliminary Performance Study
Eligible Glaucoma patients will undergo pre-surgery examination including:
medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .
The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery.
Patients will be followed up to 24 weeks post operation.
Read the detailed description
Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.
Description of MIMS procedure:
on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .
creating drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue].MIMS procedure may be combined with cataract surgery.
Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least one month.
Patients will be followed up to 24 weeks post operation.
The following measurements will be included:
- Intra Ocular Pressure (IOP)
- Best Corrected Visual Acuity (BCVA)
- Slit Lamp Biomicroscopic evaluation
- Anterior Segment Optical coherence tomography (OCT)
- Fundus Examination
- Conditions
- Glaucoma
- Being tested
- Minimally Invasive Micro Sclerostomy (MIMS)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Micro Sclerostomy (MIMS)Device
The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive micro sclerostomy (MIMS) | Experimental | create a drainage channel at the sclera-corneal junction Receives: Device: Minimally Invasive Micro Sclerostomy (MIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event
Overall incidence of serious adverse events
Measured: 12 weeks
Drainage Channel Creation
Ability to successfully perform a drainage channel
Measured: Index procedure day
Secondary outcomes (2)
Serious Adverse Event
Overall incidence of serious adverse events
Measured: 24 Weeks
Intraocular Pressure
Intraocular Pressure between 6 mmHg and 20 mmHg
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start16 Jul 2018
- Primary completion2 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanoculis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484155
- Sponsor's protocol ID
- MMS-072-51
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geffen N, Kumar DA, Barayev E, Gershoni A, Rotenberg M, Zahavi A, Glovinsky Y, Agarwal A. Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. J Glaucoma. 2022 Mar 1;31(3):191-200. doi: 10.1097/IJG.0000000000001955.
PubMed 34731867
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Micro Sclerostomy: First in Man (FIM) Safety and Preliminary Performance Study
- ClinicalTrials.gov ID
- NCT04484155
- Acronym / sponsor ID
- MMS-072-51
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible Glaucoma patients will undergo pre-surgery examination including:
medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .
The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery.
Patients will be followed up to 24 weeks post operation.
Detailed description
Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.
Description of MIMS procedure:
on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .
creating drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue].MIMS procedure may be combined with cataract surgery.
Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least one month.
Patients will be followed up to 24 weeks post operation.
The following measurements will be included:
- Intra Ocular Pressure (IOP)
- Best Corrected Visual Acuity (BCVA)
- Slit Lamp Biomicroscopic evaluation
- Anterior Segment Optical coherence tomography (OCT)
- Fundus Examination
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive micro sclerostomy (MIMS) | Experimental | Device: Minimally Invasive Micro Sclerostomy (MIMS)create a drainage channel at the sclera-corneal junction |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years
- End stage Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
- Optic nerve appearance characteristic of glaucoma in the study eye
- Best-corrected visual acuity (BCVA) with ETDRS charts ≤ 6/60
- Patient is treated with 0 to 5 hypotensive medications in the study eye
Key exclusion criteria (22 listed)
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL.
- Congenital or developmental glaucoma in either eye
- Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
- Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Micro Sclerostomy (MIMS)The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool. | Device | Minimally invasive micro sclerostomy (MIMS) |
Primary outcome
Serious Adverse Event
Time frame: 12 weeks
Overall incidence of serious adverse events
Drainage Channel Creation
Time frame: Index procedure day
Ability to successfully perform a drainage channel
2 secondary outcomes
Serious Adverse Event
Time frame: 24 Weeks
Intraocular Pressure
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 34731867Geffen N, Kumar DA, Barayev E, Gershoni A, Rotenberg M, Zahavi A, Glovinsky Y, Agarwal A. Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. J Glaucoma. 2022 Mar 1;31(3):191-200. doi: 10.1097/IJG.0000000000001955.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Micro Sclerostomy (MIMS) in people with Glaucoma, run by Sanoculis Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Event (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.