Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
279 participants
OBSERVATIONAL
2020-05-22
2022-11-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
InnFocus MicroShunt Versus Trabeculectomy Study
NCT01881425
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
NCT04440527
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
NCT07235592
Post Market Study of the InnFocus MicroShunt
NCT02177123
SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.
NCT03931564
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MicroShunt treatment group
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device
PRESERFLO® MicroShunt
Device surgically implanted
Trabeculectomy control arm
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure
Trabeculectomy
The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRESERFLO® MicroShunt
Device surgically implanted
Trabeculectomy
The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Exclusion Criteria
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InnFocus Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Palmberg, MD, PhD
Role: STUDY_DIRECTOR
Bascolm Palmer Eye Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Advance Eye Research Institute, LLC.
Glendale, Arizona, United States
Vold Vision
Fayetteville, Arkansas, United States
UCLA Medical Center Jules Stein Eye Institute
Los Angeles, California, United States
University of California at Davis Eye Center
Sacramento, California, United States
Ophthalmic Consultants of Connecticut
Meriden, Connecticut, United States
Intermountain Eye Center
Eagle, Idaho, United States
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, United States
Stiles Eye Care Excellence & Glaucoma Institute
Overland Park, Kansas, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States
New York Eye and Ear Infirmary of Mt. Sinai
New York, New York, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
University Eye Associates
Houston, Texas, United States
R&R Eye Research, LLC
San Antonio, Texas, United States
Pôle Ophtalmologique de la Clinique Mutualiste
Pessac, Bordeaux, France
A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello
Pisa, Cisanello, Italy
Hospital Clínico San Carlos
Madrid, , Spain
Moorfields Eye Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INN005 - EXT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.