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InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01881425
Recruitment Status : Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Procedure: Glaucoma Surgery Device: InnFocus MicroShunt Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 857 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : June 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. > 20% decrease in diurnal intraocular pressure [ Time Frame: 1 year ]
    The primary effectiveness outcome is > 20% IOP reduction from baseline to 12 months follow-up.


Secondary Outcome Measures :
  1. Reduction in diurnal intraocular pressure [ Time Frame: 1 year ]
    The secondary effectiveness outcome is the reduction in diurnal intraocular pressure from baseline to 12 months post-operative examination.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881425


  Show 29 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
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by InnFocus Inc.:
POAG

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