Primary Open Angle GlaucomaNCT02355990
Minimally Invasive Micro Sclerostomy First in Man Safety and Preliminary Performance Study
A study testing Minimally Invasive Micro Sclerostomy in people with Primary Open Angle Glaucoma and Pigmentary Glaucoma, run by Sanoculis Ltd at 1 site in Israel.
Trial summary
The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliative Glaucoma
- What is being tested?
- Minimally Invasive Micro Sclerostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2015to 15 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End Stage primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye (EGS criteria)
- Optic nerve appearance characteristic of glaucoma in the study eye
- Best-corrected visual acuity (BCVA) of counting-fingers, hand movements, light perception or no light perception due to glaucomatous loss of central vision in the study eye
- Patient is treated with 1 to 5 hypotensive medications in the study eye
- Unsatisfactory medicated IOP (≥ 18 mmHg) at the screening visit in the study eye
- 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
- Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- Closed angle forms of glaucoma in either eye
- 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
Show all 23Show fewer
- Subject has history of penetrating keratoplasty (PKP)
- 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
- Less than the minimum visual function required for driving in the fellow eye: best-corrected visual acuity worse than 20/40 (Snellen equivalent) or Esterman visual field score less than 85%.
- 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, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
- 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.
Israel1 site
Goldschleger Eye Institute, The Chaim Sheba Medical Center
Tel HaShomer
About this study
The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.
- Being tested
- Minimally Invasive Micro Sclerostomy
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Micro SclerostomyProcedure or surgery
Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).
| Study group | Role | What they receive |
|---|---|---|
| MIMS | Experimental | Minimally Invasive Micro Sclerostomy Receives: Procedure: Minimally Invasive Micro Sclerostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of serious adverse events
Measured: 12 weeks
Secondary outcomes (3)
Incidence of serious adverse events
Measured: 24 weeks
intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication
Measured: 24 weeks
Change in number of glaucoma medications from baseline in the study eye
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 posted4 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Jan 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanoculis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Cotlear, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355990
- Sponsor's protocol ID
- SAN-FIM-1
- Status last verified
- Nov 2022
- First submitted
- 31 Jan 2015
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
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 Safety and Preliminary Performance Study
- ClinicalTrials.gov ID
- NCT02355990
- Acronym / sponsor ID
- SAN-FIM-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 4 Feb 2015 (estimated)
- 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.
The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIMS | Experimental | Procedure: Minimally Invasive Micro SclerostomyMinimally Invasive Micro Sclerostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- End Stage primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye (EGS criteria)
- Optic nerve appearance characteristic of glaucoma in the study eye
- Best-corrected visual acuity (BCVA) of counting-fingers, hand movements, light perception or no light perception due to glaucomatous loss of central vision in the study eye
- Patient is treated with 1 to 5 hypotensive medications in the study eye
- Unsatisfactory medicated IOP (≥ 18 mmHg) at the screening visit in the study eye
Key exclusion criteria (23 listed)
- Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
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 SclerostomyCreation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space). | Procedure or surgery | MIMS |
Primary outcome
Overall incidence of serious adverse events
Time frame: 12 weeks
3 secondary outcomes
Incidence of serious adverse events
Time frame: 24 weeks
intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication
Time frame: 24 weeks
Change in number of glaucoma medications from baseline in the study eye
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.
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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.
Daniel Cotlear, MD principal investigator
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 in people with Primary Open Angle Glaucoma and Pigmentary Glaucoma, run by Sanoculis Ltd at 1 site in Israel.
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 8 inclusion and 23 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 Israel. 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?
Overall incidence of serious adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.