NCT02177123

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 28, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

3.7 years

First QC Date

June 26, 2014

Results QC Date

January 26, 2021

Last Update Submit

June 22, 2021

Conditions

Primary Open Angle Glaucoma

Keywords

glaucoma shuntglaucoma drainage device

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Study Success

    Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population

    Month 6, 9, 12, and 24

Secondary Outcomes (1)

  • IOP Change

    Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24

Other Outcomes (1)

  • Number of Participants Requiring Supplemental Medical Therapy at M12 and M24

    12 and 24 Months

Study Arms (1)

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)

Device: InnFocus MicroShunt implantation

Interventions

InnFocus MicroShunt implantationDEVICE

Implantation will include the use of Mitomycin C applied with sponges.

Also known as: InnFocus MicroShunt, MIDI Arrow
InnFocus MicroShunt Surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \) Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form

You may not qualify if:

  • 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.
  • 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.
  • +37 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique Ophtalmologique Universitaire de Grenoble, Hôpital A. Michallon - CHU de Grenoble

Grenoble, 38043, France

Location

Groupe hospitalier Paris Saint-Joseph, Service d'Ophtalmologie

Paris, 75674, France

Location

Pole Ophtalmologique de la Clinique Mutualiste

Pessac, 33608, France

Location

University Eye Clinic Maastricht

Maastricht, 6229 HX, Netherlands

Location

Clinicovision - Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hôpitaux Universitaires de Genève, Policlinique d'Ophtalmologie

Geneva, CH-1211, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 40408035DERIVED

  • Beckers 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.

    PMID: 34329772DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Results Point of Contact

Title
Sharon Herbert, Associate Director of Clinical Operations
Organization
InnFocus, Inc.
sharon.herbert@santen.com
(415) 268-9059

Study Officials

  • Guy Van de Weyer, Optometrist

    InnFocus Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

April 4, 2014

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

June 24, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-06

Locations

NL(1)FR(3)ES(1)CH(1)