Primary Open Angle GlaucomaIMSNCT01881425
InnFocus MicroShunt Versus Trabeculectomy Study
A study testing Glaucoma Surgery and InnFocus MicroShunt in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 29 sites in 6 countries.
Trial summary
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Glaucoma Surgery and InnFocus MicroShunt
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 15 Dec 2015to 15 Jan 2020
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States24 sites
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Specialty Eye Care
Bellevue, Washington, 98004
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431
Washington Eye Physicians and Surgeons
Chevy Chase, Maryland, 20815
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio, 43215
Glaucoma Associates of Texas
Dallas, Texas, 75231
University of California at Davis Eye Center
Davis, California, 95817
Inter-Mountain Eye Care
Eagle, Idaho, 83616
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates
Fort Worth, Texas, 76102
Eye Physicians and Surgeons of Arizona
Glendale, Arizona, 85306
Chicago Glaucoma Consultants and CGC Eye Center
Glenview, Illinois, 60026
The Robert Cizik Eye Clinic
Houston, Texas, 77030
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, 46290
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
New York Eye and Ear Infirmary of Mt. Sinai
New York, New York, 10003
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Midwest Eye Surgery Center
Omaha, Nebraska, 68131
Stiles Eyecare Excellence
Overland Park, Kansas, 66213
Rashid, Rice, Flynn and Reilley Eye Associates
San Antonio, Texas, 78229
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Arizona Eye Consultants
Tucson, Arizona, 85710
France1 site
Pole Ophtalmologique de la Clinique Mutualiste
Pessac, Bordeaux, 33600
About this study
Official title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.
Read the detailed description
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.
Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Glaucoma Surgery, InnFocus MicroShunt
- Keywords
- POAG
- 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.
Glaucoma SurgeryProcedure or surgery
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.
InnFocus MicroShuntDevice
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| InnFocus MicroShunt | Experimental | InnFocus MicroShunt Receives: Device: InnFocus MicroShunt |
| Trabeculectomy | Active comparator | glaucoma surgery to reduce IOP Receives: Procedure: Glaucoma Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Measured: 12 months
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
Measured: 24 months
Secondary outcomes (4)
Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.
Measured: 12 months
Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
Measured: 24 months
Number of Participants With Postoperative Interventions at 12 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.
Measured: 12 months
Participants With Postoperative Interventions at 24 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start15 Dec 2015
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnFocus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Palmberg, M.D., Ph.D., Study director, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881425
- Sponsor's protocol ID
- INN005
- Acronym
- IMS
- Status last verified
- Oct 2022
- First submitted
- 17 Jun 2013
- Last updated
- 26 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PubMed 36912740Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.
PubMed 34051211
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01881425
- Acronym / sponsor ID
- IMS / INN005
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- POAG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- InnFocus Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Posted 26 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.
Detailed description
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.
Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InnFocus MicroShunt | Experimental | Device: InnFocus MicroShuntInnFocus MicroShunt |
| Trabeculectomy | Active comparator | Procedure: Glaucoma Surgeryglaucoma surgery to reduce IOP |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Glaucoma SurgeryAn initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure. | Procedure or surgery | Trabeculectomy |
| InnFocus MicroShuntAn initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure. | Device | InnFocus MicroShunt |
Primary outcome
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
Time frame: 12 months
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
Time frame: 24 months
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
4 secondary outcomes
Mean Diurnal Intraocular Pressure Change
Time frame: 12 months
Mean Diurnal Intraocular Pressure Change
Time frame: 24 months
Number of Participants With Postoperative Interventions at 12 Months
Time frame: 12 months
Participants With Postoperative Interventions at 24 Months
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36912740Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
- Derived from this study: PubMed 34051211Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.
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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.
Paul Palmberg, M.D., Ph.D. study director
Bascom Palmer Eye Institute
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma Surgery and InnFocus MicroShunt in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 29 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Italy, Netherlands, Spain and 1 more country. 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 26 Oct 2022). 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 > 20% Decrease in Mean Diurnal Intraocular Pressure (time frame: 12 months). 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 NCT01881425, 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 26 Oct 2022.