Primary Open Angle GlaucomaNCT02177123
Post Market Study of the InnFocus MicroShunt
A study testing InnFocus MicroShunt implantation in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 6 sites in 4 countries.
Trial summary
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- InnFocus MicroShunt implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 4 Apr 2014to 27 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
- Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos:
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.
- Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
- Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
- 4) Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form
Who cannot join
- Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
- Iridocorneal endothelial syndrome.
- Epithelial or fibrous downgrowth.
- Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
- Chronic ocular inflammatory disease.
- Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
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- Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
- Severe anterior or posterior blepharitis.
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- Prior laser peripheral iridotomy.
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- Previous cyclodestructive procedure.
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- Severe anterior or posterior blepharitis.
- Unwilling to discontinue contact lens use after surgery.
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- Presence of an anterior chamber IOL (AC-IOL).
- Prior laser peripheral iridotomy.
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- Known allergy or other contraindication to Mitomycin C (MMC) drug.
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring).
- Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization).
- Central corneal thickness that is less than 450 microns or greater than 620 microns.
- Previous cyclodestructive procedure.
- Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
- Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
- Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
- Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits),
- inability to reliably complete visual field testing over the course of the study,
- uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
- Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
- inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
- immunodeficiency concerns.
- known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
- Intraocular silicone oil.
- Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.)
- Chemotherapy within six months of the screening visit.
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- A requirement of general anesthesia for the procedure.
- Bacterial conjunctivitis
- Bacterial corneal ulcers
- Endophthalmitis
- Orbital cellulitis
- Bacteremia or septicemia
- Active scleritis
- Uveitis
- Severe dry eye syndrome
- Severe myopia
- Pseudo-exfoliative glaucoma
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France3 sites
Clinique Ophtalmologique Universitaire de Grenoble, Hôpital A. Michallon - CHU de Grenoble
Grenoble, 38043
Groupe hospitalier Paris Saint-Joseph, Service d'Ophtalmologie
Paris, 75674
Pole Ophtalmologique de la Clinique Mutualiste
Pessac, 33608
Switzerland1 site
Hôpitaux Universitaires de Genève, Policlinique d'Ophtalmologie
Geneva, CH-1211
About this study
Official title: Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients
Read the detailed description
The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- InnFocus MicroShunt implantation
- Keywords
- glaucoma shunt, glaucoma drainage device
- 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.
InnFocus MicroShunt implantationDevice
Also called InnFocus MicroShunt, MIDI Arrow
Implantation will include the use of Mitomycin C applied with sponges.
| Study group | Role | What they receive |
|---|---|---|
| InnFocus MicroShunt Surgery | Experimental | InnFocus MicroShunt implantation in the anterior chamber of the eye on patients with primary open angle glaucoma after am antiproliferative treatment of mitomycin C (MMC) Receives: Device: InnFocus MicroShunt implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Study Success
Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population
Measured: Month 6, 9, 12, and 24
Secondary outcomes (1)
IOP Change
IOP relative to the pre-operative value was assessed at each post-operative visit (Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24).
Measured: Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start4 Apr 2014
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnFocus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Van de Weyer, Optometrist, Study director, InnFocus Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177123
- Sponsor's protocol ID
- INN-007
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2014
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23.
PubMed 40408035Beckers HJM, Aptel F, Webers CAB, Bluwol E, Martinez-de-la-Casa JM, Garcia-Feijoo J, Lachkar Y, Mendez-Hernandez CD, Riss I, Shao H, Pinchuk L, Angeles R, Sadruddin O, Shaarawy TM. Safety and Effectiveness of the PRESERFLO(R) MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. Epub 2021 Jul 28.
PubMed 34329772
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02177123
- Acronym / sponsor ID
- INN-007
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- glaucoma shunt, glaucoma drainage device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- InnFocus Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2014 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients
Detailed description
The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InnFocus MicroShunt Surgery | Experimental | Device: InnFocus MicroShunt implantationInnFocus MicroShunt implantation in the anterior chamber of the eye on patients with primary open angle glaucoma after am antiproliferative treatment of mitomycin C (MMC) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
- Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos:
- 4) Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form
Key exclusion criteria (52 listed)
- Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
- Iridocorneal endothelial syndrome.
- Epithelial or fibrous downgrowth.
- Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
- Chronic ocular inflammatory disease.
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 |
|---|---|---|
| InnFocus MicroShunt implantationAlso: InnFocus MicroShunt, MIDI ArrowImplantation will include the use of Mitomycin C applied with sponges. | Device | InnFocus MicroShunt Surgery |
Primary outcome
Number of Participants With Study Success
Time frame: Month 6, 9, 12, and 24
Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population
1 secondary outcome
IOP Change
Time frame: Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40408035Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23.
- Derived from this study: PubMed 34329772Beckers HJM, Aptel F, Webers CAB, Bluwol E, Martinez-de-la-Casa JM, Garcia-Feijoo J, Lachkar Y, Mendez-Hernandez CD, Riss I, Shao H, Pinchuk L, Angeles R, Sadruddin O, Shaarawy TM. Safety and Effectiveness of the PRESERFLO(R) MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. Epub 2021 Jul 28.
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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.
Guy Van de Weyer, Optometrist study director
InnFocus Inc.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnFocus MicroShunt implantation in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 6 sites in 4 countries.
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 7 inclusion and 52 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Netherlands, Spain, Switzerland. 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?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Study Success (time frame: Month 6, 9, 12, and 24). 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 NCT02177123, which also lists 2 linked publications.
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 24 Jun 2021.