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InnFocus MicroShunt Versus Trabeculectomy Study (IMS)

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Glaucoma Surgery
InnFocus MicroShunt
Sponsored by
InnFocus Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring POAG

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • Eye Physicians and Surgeons of Arizona
  • Arizona Eye Consultants
  • Vold Vision
  • University of California at Davis Eye Center
  • UCLA Jules Stein Eye Institute
  • Ophthalmic Consultants of Connecticut
  • Inter-Mountain Eye Care
  • Chicago Glaucoma Consultants and CGC Eye Center
  • Eugene and Marilyn Glick Eye Institute
  • Stiles Eyecare Excellence
  • Washington Eye Physicians and Surgeons
  • Minnesota Eye Consultants, PA
  • Midwest Eye Surgery Center
  • New York Eye and Ear Infirmary of Mt. Sinai
  • Glaucoma Consultants of the Capital Region
  • Cincinnati Eye Institute
  • Ophthalmic Surgeons and Consultants of Ohio
  • Dean McGee Eye Institute
  • Ophthalmic Partners of Pennsylvania
  • Glaucoma Associates of Texas
  • Ophthalmology Associates
  • The Robert Cizik Eye Clinic
  • Rashid, Rice, Flynn and Reilley Eye Associates
  • Specialty Eye Care
  • Pole Ophtalmologique de la Clinique Mutualiste
  • Pisa University Hospital Cisanello
  • University Eye Clinic Maastricht
  • Hospital Clínico San Carlos
  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

InnFocus MicroShunt

Trabeculectomy

Arm Description

InnFocus MicroShunt

glaucoma surgery to reduce IOP

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.
Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
Number of Participants With Postoperative Interventions at 12 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.
Participants With Postoperative Interventions at 24 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.

Full Information

First Posted
June 17, 2013
Last Updated
October 25, 2022
Sponsor
InnFocus Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01881425
Brief Title
InnFocus MicroShunt Versus Trabeculectomy Study
Acronym
IMS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnFocus Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
POAG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InnFocus MicroShunt
Arm Type
Experimental
Arm Description
InnFocus MicroShunt
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
glaucoma surgery to reduce IOP
Intervention Type
Procedure
Intervention Name(s)
Glaucoma Surgery
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
InnFocus MicroShunt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
Description
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Time Frame
12 months
Title
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
Description
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure Change
Description
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.
Time Frame
12 months
Title
Mean Diurnal Intraocular Pressure Change
Description
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
Time Frame
24 months
Title
Number of Participants With Postoperative Interventions at 12 Months
Description
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.
Time Frame
12 months
Title
Participants With Postoperative Interventions at 24 Months
Description
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Palmberg, M.D., Ph.D.
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
Eye Physicians and Surgeons of Arizona
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Eye Consultants
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
University of California at Davis Eye Center
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCLA Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ophthalmic Consultants of Connecticut
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Inter-Mountain Eye Care
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Chicago Glaucoma Consultants and CGC Eye Center
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Eugene and Marilyn Glick Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Stiles Eyecare Excellence
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Washington Eye Physicians and Surgeons
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Minnesota Eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Midwest Eye Surgery Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Glaucoma Consultants of the Capital Region
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Ophthalmic Surgeons and Consultants of Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Ophthalmic Partners of Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Facility Name
The Robert Cizik Eye Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Rashid, Rice, Flynn and Reilley Eye Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Specialty Eye Care
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Pole Ophtalmologique de la Clinique Mutualiste
City
Pessac
State/Province
Bordeaux
ZIP/Postal Code
33600
Country
France
Facility Name
Pisa University Hospital Cisanello
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
University Eye Clinic Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34051211
Citation
Baker 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.
Results Reference
derived

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InnFocus MicroShunt Versus Trabeculectomy Study

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