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
  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:
  • 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.


Secondary Outcome Measures:
  • > 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.


Estimated Enrollment: 857
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (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 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.
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. 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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

Locations
United States, Arkansas
Vold Vision Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Scott Hewitt    479-442-8653    shewitt@voldvision.com   
Contact: Steven Vold, M.D.    479-442-8653      
Principal Investigator: Steven Vold, MD         
United States, Connecticut
Ophthalmic Consultants of Connecticut Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Denise Lavin    203-366-8000    dlavin@occeye.com   
Contact: Robert Noecker, M.D.    203-366-8000      
Principal Investigator: Robert Noecker, MD         
United States, Idaho
Inter-Mountain Eye Care Recruiting
Eagle, Idaho, United States, 83616
Contact: Jill Heinz    208-841-8624    jill.tvcr@gmail.com   
Contact: Adam Reynolds, M.D.    208-918-4712      
Principal Investigator: Adam Reynolds, M.D.         
United States, Indiana
Eugene and Marilyn Glick Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Joni Hoop    317-274-8975    jhoop@iupui.edu   
Contact: Linda Morgan    317-274-8975    lismorga@iupui.edu   
Principal Investigator: Louis Cantor, M.D.         
United States, Kansas
Stiles Eyecare Excellence Recruiting
Overland Park, Kansas, United States, 66213
Contact: Russ Schroeder    913-897-9299    RSchroeder@Stileseye.com   
Contact: Michael Stiles, M.D.    (913) 897-9299      
Principal Investigator: Michael Stiles, MD         
United States, Maryland
Washington Eye Physicians and Surgeons Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Albert Tzeng    301-657-5700    amtzeng@gmail.com   
Contact: Kenneth Schwartz, M.D.    301-657-5700      
Principal Investigator: Kenneth Schwartz, M.D.         
United States, Ohio
Ohio Eye Alliance Recruiting
Alliance, Ohio, United States, 44601
Contact: Richard Lehrer, M.D.    330-823-1680      
Contact: William Patton, OD    330-823-1680      
Principal Investigator: Richard Lehrer, M.D.         
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sonny Icks    405-271-6307    Sonny-Icks@dmei.org   
Contact: Mahmoud Khaimi, M.D.    405-271-6060      
Principal Investigator: Mahmoud Khaimi, M.D.         
United States, Texas
The Robert Cizik Eye Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Laura Baker    713-559-5200    LauraBaker@cizikeye.org   
Contact: Robert Feldman, M.D.    713-559-5200      
Principal Investigator: Robert Feldman, M.D.         
United States, Washington
Specialty Eye Care Recruiting
Bellevue, Washington, United States, 98004
Contact: Renee Cook    425-454-3937    rcook@specialtyeyecarecentre.com   
Contact: Howard Barnebey, M.D.    (425) 454-3937      
Principal Investigator: Howard Barneby, MD         
Sponsors and Collaborators
InnFocus Inc.
Investigators
Study Director: Paul Palmberg, M.D., Ph.D. Bascom Palmer Eye Institute
  More Information

No publications provided

Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT01881425     History of Changes
Other Study ID Numbers: INN005
Study First Received: June 17, 2013
Last Updated: June 16, 2014
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 July 22, 2014