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Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

Primary Purpose

Primary Open Angle Glaucoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MIDI Arrow

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
Less than 0.1 (20/200) visual acuity in the non-test eye.
Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.

Sites / Locations

Clinique Mutualiste - Pavillon Ophtalmogique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIDI Arrow

Arm Description

Implantation of MIDI Arrow

Outcomes

Primary Outcome Measures

Number of Eyes With Study Success

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

Secondary Outcome Measures

IOP Change From Baseline

Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.

Full Information

NCT ID

NCT01563237

First Posted

March 21, 2012

Last Updated

June 22, 2021

Sponsor

InnFocus Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01563237

Brief Title

Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

Official Title

Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InnFocus Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIDI Arrow

Arm Type

Experimental

Arm Description

Implantation of MIDI Arrow

Intervention Type

Device

Intervention Name(s)

MIDI Arrow

Other Intervention Name(s)

Glaucoma drainage device implantation

Intervention Description

Implantation of MIDI Arrow

Primary Outcome Measure Information:

Title

Number of Eyes With Study Success

Description

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

Time Frame

Months 6, 9, 12 and 24

Secondary Outcome Measure Information:

Title

IOP Change From Baseline

Description

Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period. Less than 0.1 (20/200) visual acuity in the non-test eye. Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle M Riss, MD

Organizational Affiliation

Clinique Mutualiste de Pessac, Pessac, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Mutualiste - Pavillon Ophtalmogique

City

Pessac

ZIP/Postal Code

33600

Country

France

12. IPD Sharing Statement

Learn more about this trial

Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

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