InnFocus MicroShunt Versus Trabeculectomy Study
IMS
A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
1 other identifier
interventional
732
6 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedStudy Start
First participant enrolled
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedResults Posted
Study results publicly available
October 26, 2022
CompletedOctober 26, 2022
October 1, 2022
4.1 years
June 17, 2013
July 11, 2022
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
12 months
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
24 months
Secondary Outcomes (4)
Mean Diurnal Intraocular Pressure Change
12 months
Mean Diurnal Intraocular Pressure Change
24 months
Number of Participants With Postoperative Interventions at 12 Months
12 months
Participants With Postoperative Interventions at 24 Months
24 months
Study Arms (2)
InnFocus MicroShunt
EXPERIMENTALInnFocus MicroShunt
Trabeculectomy
ACTIVE COMPARATORglaucoma surgery to reduce IOP
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InnFocus Inc.lead
Study Sites (29)
Eye Physicians and Surgeons of Arizona
Glendale, Arizona, 85306, United States
Arizona Eye Consultants
Tucson, Arizona, 85710, United States
Vold Vision
Fayetteville, Arkansas, 72704, United States
University of California at Davis Eye Center
Davis, California, 95817, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824, United States
Inter-Mountain Eye Care
Eagle, Idaho, 83616, United States
Chicago Glaucoma Consultants and CGC Eye Center
Glenview, Illinois, 60026, United States
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, 46290, United States
Stiles Eyecare Excellence
Overland Park, Kansas, 66213, United States
Washington Eye Physicians and Surgeons
Chevy Chase, Maryland, 20815, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431, United States
Midwest Eye Surgery Center
Omaha, Nebraska, 68131, United States
New York Eye and Ear Infirmary of Mt. Sinai
New York, New York, 10003, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio, 43215, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
Ophthalmology Associates
Fort Worth, Texas, 76102, United States
The Robert Cizik Eye Clinic
Houston, Texas, 77030, United States
Rashid, Rice, Flynn and Reilley Eye Associates
San Antonio, Texas, 78229, United States
Specialty Eye Care
Bellevue, Washington, 98004, United States
Pole Ophtalmologique de la Clinique Mutualiste
Pessac, Bordeaux, 33600, France
Pisa University Hospital Cisanello
Pisa, 56126, Italy
University Eye Clinic Maastricht
Maastricht, 6229 HX, Netherlands
Hospital Clínico San Carlos
Madrid, 28040, Spain
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Related Publications (2)
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PMID: 36912740DERIVEDBaker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.
PMID: 34051211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Herbert, Director of Global Clinical Operations
- Organization
- InnFocus, Inc. (a Santen Company)
Study Officials
- STUDY DIRECTOR
Paul Palmberg, M.D., Ph.D.
Bascom Palmer Eye Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 19, 2013
Study Start
December 15, 2015
Primary Completion
January 15, 2020
Study Completion
January 15, 2020
Last Updated
October 26, 2022
Results First Posted
October 26, 2022
Record last verified: 2022-10