NCT01563237

Brief Summary

To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
4.4 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

5.5 years

First QC Date

March 21, 2012

Results QC Date

January 26, 2021

Last Update Submit

June 22, 2021

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Number of Eyes With Study Success

    The rate of success reflected sustained control of IOP over 24 Months from baseline

    Months 6, 9, 12 and 24

Secondary Outcomes (1)

  • IOP Change From Baseline

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

Study Arms (1)

MIDI Arrow

EXPERIMENTAL

Implantation of MIDI Arrow

Device: MIDI Arrow

Interventions

MIDI ArrowDEVICE

Implantation of MIDI Arrow

Also known as: Glaucoma drainage device implantation
MIDI Arrow

Eligibility Criteria

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

You may qualify if:

  • Male or female patient, age 18 to 85 years, inclusive
  • Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
  • Patient must have signed and dated the Informed Consent form

You may not qualify if:

  • Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
  • Pregnant or nursing women.
  • No light perception.
  • Active iris neovascularization or active proliferative retinopathy.
  • Iridocorneal endothelial syndrome.
  • Epithelial or fibrous downgrowth.
  • Pseudoexfoliative glaucoma
  • Aphakia.
  • Vitreous in anterior chamber for which a vitrectomy is anticipated.
  • Corneal disease
  • Acute, chronic or recurrent uveitis.
  • Severe posterior blepharitis.
  • Unwilling to discontinue contact lens use after surgery.
  • Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
  • Prior cataract surgery involving a conjunctival incision
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Mutualiste - Pavillon Ophtalmogique

Pessac, 33600, France

Location

Related Publications (1)

  • 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

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

  • Isabelle M Riss, MD

    Clinique Mutualiste de Pessac, Pessac, France

    PRINCIPAL INVESTIGATOR

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

March 21, 2012

First Posted

March 26, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 24, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-06

Locations

FR(1)