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InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

This study is currently recruiting participants.
Verified September 2017 by InnFocus Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881425
First Posted: June 19, 2013
Last Update Posted: September 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
InnFocus Inc.
June 17, 2013
June 19, 2013
September 19, 2017
June 2013
July 2018   (Final data collection date for primary outcome measure)
> 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.
Reduction in intraocular pressure [ Time Frame: 2 years ]
The primary effectiveness outcome is the hypotensive medication-free diurnal mean IOP reduction from baseline to 24 months follow-up.
Complete list of historical versions of study NCT01881425 on ClinicalTrials.gov Archive Site
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.
> 20% decrease in hypotensive medication-free diurnal intraocular pressure [ Time Frame: 2 years ]
The secondary effectiveness outcome is the proportion of eyes with ≥ 20% decrease in hypotensive medication-free diurnal intraocular pressure from baseline to 24 months post-operative examination.
Not Provided
Not Provided
 
InnFocus MicroShunt Versus Trabeculectomy Study
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
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Primary Open Angle Glaucoma
  • 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.
  • 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.
  • Experimental: InnFocus MicroShunt
    InnFocus MicroShunt
    Intervention: Device: InnFocus MicroShunt
  • Active Comparator: Trabeculectomy
    glaucoma surgery to reduce IOP
    Intervention: Procedure: Glaucoma Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
857
July 2019
July 2018   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact: Haydee Frost, CCRC 305-378-2651 ext 246 haydee.frost@santen.com
France,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
 
 
NCT01881425
INN005
Yes
Not Provided
Not Provided
InnFocus Inc.
InnFocus Inc.
Not Provided
Study Director: Paul Palmberg, M.D., Ph.D. Bascom Palmer Eye Institute
InnFocus Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP