InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by InnFocus Inc.
Sponsor:
Information provided by (Responsible Party):
InnFocus Inc.
ClinicalTrials.gov Identifier:
NCT01881425
First received: June 17, 2013
Last updated: June 16, 2014
Last verified: June 2014

June 17, 2013
June 16, 2014
June 2013
June 2017   (final data collection date for primary outcome measure)
Reduction in intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary effectiveness outcome is the diurnal mean IOP reduction from baseline to 24 months follow-up.
Reduction in intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
> 20% decrease in diurnal intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The secondary effectiveness outcome is the proportion of eyes with ≥ 20% decrease in diurnal intraocular pressure from baseline to 24 months post-operative examination.
> 20% decrease in hypotensive medication-free diurnal intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value.

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, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 a 25Ga needle enters through the shallow pocket and enters the AC. The device is then threaded through the needle 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
September 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥18mmHg and ≤35mmHg - Diurnal unmedicated IOP >21mmHg and <40mmHg Exclusion Criteria: - Previous incisional ophthalmic surgery except for cataract 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

Both
40 Years to 85 Years
No
United States
 
NCT01881425
INN005
Yes
InnFocus Inc.
InnFocus Inc.
Not Provided
Study Director: Paul Palmberg, M.D., Ph.D. Bascom Palmer Eye Institute
InnFocus Inc.
June 2014

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