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Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Dominican Republic

Study Type

Interventional

Intervention

Glaucoma Drainage Device

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring MIDI Arrow, Glaucoma Drainage Device, GDD, InnFocus, Glaucoma treatment

Eligibility Criteria

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

Inclusion Criteria:

Male or female, age 18 to 85 years, inclusive
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 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
Aphakia (without pseudophakia)
Vitreous in anterior chamber for which a vitrectomy is anticipated
Chronic or recurrent uveitis
Severe posterior blepharitis
Unwilling to discontinue contact lens use after surgery
Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery
Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery
Known allergy to Mitomycin C (MMC) drug.

Sites / Locations

Laser Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIDI Arrow

Arm Description

Ab externo glaucoma drainage device with no reservoir

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Performance Success

Success: IOP < 15 mmHg or IOP reduced from baseline (pre-operative level) by ≥ 20% (without glaucoma reoperation, such as a trabeculectomy to improve aqueous drainage or implantation of another drainage implant).

Secondary Outcome Measures

Maintenance of Pressure Control

Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit

Full Information

NCT ID

NCT00772330

First Posted

October 13, 2008

Last Updated

June 23, 2021

Sponsor

InnFocus Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00772330

Brief Title

Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Official Title

Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

November 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

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from 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.

Detailed Description

Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I & II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions

6. Conditions and Keywords

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

Glaucoma

Keywords

MIDI Arrow, Glaucoma Drainage Device, GDD, InnFocus, Glaucoma treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIDI Arrow

Arm Type

Experimental

Arm Description

Ab externo glaucoma drainage device with no reservoir

Intervention Type

Device

Intervention Name(s)

Glaucoma Drainage Device

Intervention Description

Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye

Primary Outcome Measure Information:

Title

Number of Participants With Treatment Performance Success

Description

Time Frame

Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

Secondary Outcome Measure Information:

Title

Maintenance of Pressure Control

Description

Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit

Time Frame

Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

Other Pre-specified Outcome Measures:

Title

Procedure Feasibility

Description

Defined by ease of insertion of the device into the anterior chamber, based on an Investigator evaluation rating (5-point scale, with 1 being difficult and 5 being easy);

Time Frame

Day 1

Title

Time (in Minutes) Taken for the Procedure

Description

The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure

Time Frame

Day 1

Title

Visual Acuity

Description

Visual acuity measured at each post-operative visit from baseline.

Time Frame

Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

Title

Visual Field

Description

Visual field measure at each post op visit. Data not available for summary as per CSR

Time Frame

60 Months

Title

Incidence of Glaucoma Re-operation

Description

Cases requiring glaucoma re-operation

Time Frame

60 Months

Title

Glaucoma Supplemental Medication

Description

The number of glaucoma supplemental medications required after the MicroShunt procedure.

Time Frame

Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

Title

Implant Migration

Description

Incidence of implant migration. None reported

Time Frame

60 Months

Title

Implant Encapsulation

Description

Incidence of implant encapsulation. None reported

Time Frame

60 Months

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, age 18 to 85 years, inclusive 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 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 Aphakia (without pseudophakia) Vitreous in anterior chamber for which a vitrectomy is anticipated Chronic or recurrent uveitis Severe posterior blepharitis Unwilling to discontinue contact lens use after surgery Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery Known allergy to Mitomycin C (MMC) drug.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan F Batlle, MD

Organizational Affiliation

Laser Center, Santo Domingo, Dominican Republic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laser Center

City

Santo Domingo

Country

Dominican Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

33137019

Citation

Batlle JF, Corona A, Albuquerque R. Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286. doi: 10.1097/IJG.0000000000001734.

Results Reference

derived

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Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

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