InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: InnFocus MicroShunt; Procedure: Glaucoma Surgery

Detailed Description

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.

Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.

• Study Type: Interventional
• Enrollment (Actual): 732
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux
    • Pessac, Bordeaux, France, 33600
      • Pôle Ophtalmologique de la Clinique Mutualiste
• Italy
  • Pisa, Italy, 56126
    • Pisa University Hospital Cisanello
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • University Eye Clinic Maastricht
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Eye Physicians and Surgeons of Arizona
    • Tucson, Arizona, United States, 85710
      • Arizona Eye Consultants
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Davis, California, United States, 95817
      • University of California at Davis Eye Center
    • Los Angeles, California, United States, 90095
      • UCLA Jules Stein Eye Institute
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Ophthalmic Consultants of Connecticut
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Inter-Mountain Eye Care
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Chicago Glaucoma Consultants and CGC Eye Center
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Eugene and Marilyn Glick Eye Institute
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Stiles Eyecare Excellence
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Washington Eye Physicians and Surgeons
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, PA
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Midwest Eye Surgery Center
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary of Mt. Sinai
    • Slingerlands, New York, United States, 12159
      • Glaucoma Consultants of the Capital Region
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Columbus, Ohio, United States, 43215
      • Ophthalmic Surgeons and Consultants of Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Ophthalmic Partners of Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates Of Texas
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates
    • Houston, Texas, United States, 77030
      • The Robert Cizik Eye Clinic
    • San Antonio, Texas, United States, 78229
      • Rashid, Rice, Flynn and Reilley Eye Associates
  • Washington
    • Bellevue, Washington, United States, 98004
      • Specialty Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InnFocus MicroShunt	Device: InnFocus MicroShunt; An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Active Comparator: Trabeculectomy; glaucoma surgery to reduce IOP	Procedure: Glaucoma Surgery; An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure	The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up	12 months
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure	The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Diurnal Intraocular Pressure Change	Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.	12 months
Mean Diurnal Intraocular Pressure Change	Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months	24 months
Number of Participants With Postoperative Interventions at 12 Months	The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.	12 months
Participants With Postoperative Interventions at 24 Months	The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.	24 months

Collaborators and Investigators

• Sponsor: InnFocus Inc.
• Investigators: Study Director: Paul Palmberg, M.D., Ph.D., Bascom Palmer Eye Institute

Publications and helpful links

General Publications

• Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: POAG
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: INN005