Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by InnFocus Inc.
Sponsor:
Information provided by (Responsible Party):
InnFocus Inc.
ClinicalTrials.gov Identifier:
NCT01881425
First received: June 17, 2013
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Primary Open Angle Glaucoma
Procedure: Glaucoma Surgery
Device: InnFocus MicroShunt
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShuntTM Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by InnFocus Inc.:

Primary Outcome Measures:
  • > 20% decrease in diurnal intraocular pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary effectiveness outcome is > 20% IOP reduction from baseline to 12 months follow-up.


Secondary Outcome Measures:
  • Reduction in diurnal intraocular pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The secondary effectiveness outcome is the reduction in diurnal intraocular pressure from baseline to 12 months post-operative examination.


Estimated Enrollment: 857
Study Start Date: June 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: InnFocus MicroShunt
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881425

Contacts
Contact: Bruce Weber, MBA 305-378-2651 ext 371 bweber@innfocusinc.com
Contact: Chi Chau, MSHS 858-305-9296 cchau@innfocusinc.com

  Show 24 Study Locations
Sponsors and Collaborators
InnFocus Inc.
Investigators
Study Director: Paul Palmberg, M.D., Ph.D. Bascom Palmer Eye Institute
  More Information

Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT01881425     History of Changes
Other Study ID Numbers: INN005 
Study First Received: June 17, 2013
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by InnFocus Inc.:
POAG

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2016