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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Glaucoma Drainage Device

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

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MIDI Arrow; Ab externo glaucoma drainage device with no reservoir	Device: Glaucoma Drainage Device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Pressure Control	Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit	Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Feasibility	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);	Day 1
Time (in Minutes) Taken for the Procedure	The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure	Day 1
Visual Acuity	Visual acuity measured at each post-operative visit from baseline.	Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Visual Field	Visual field measure at each post op visit. Data not available for summary as per CSR	60 Months
Incidence of Glaucoma Re-operation	Cases requiring glaucoma re-operation	60 Months
Glaucoma Supplemental Medication	The number of glaucoma supplemental medications required after the MicroShunt procedure.	Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Implant Migration	Incidence of implant migration. None reported	60 Months
Implant Encapsulation	Incidence of implant encapsulation. None reported	60 Months

Collaborators and Investigators

• Sponsor: InnFocus Inc.
• Investigators: Principal Investigator: Juan F Batlle, MD, Laser Center, Santo Domingo, Dominican Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (ESTIMATE): October 15, 2008

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Glaucoma Drainage Device; GDD; MIDI Arrow; InnFocus; Glaucoma treatment
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: INN003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No