Minnesota Eye Consultants' Clinical Research Department was created to ensure high quality pre-clinical and clinical trials in vision research. Clinical research is an important component of their practice because it extends new technologies to patients and increases the overall standard of vision care. Minnesota Eye Consultants' physicians, surgeons and researchers have participated in vision research studies for years, and were among a select group of individuals whose contributions led to many of the refractive surgery technologies in use today.
The research team is led by David R. Hardten, M.D., F.A.C.S., founding partner and board-certified ophthalmologist with sub-specialty expertise in corneal, refractive and laser surgery. Research study success begins with a dedicated team of researchers and medical personnel who have years of experience in clinical trials, consulting and management. The research team is comprised of ophthalmologists, doctors of optometry and fellows, a clinical research manager, clinical research coordinators, a certified ophthalmic medical technologist and a clinical research receptionist and is located at the Minneapolis clinic of Minnesota Eye Consultants. Research activities are conducted within its metro-area clinics.
Minnesota Eye Consultants' internationally recognized team of surgeons and researchers is dedicated to improving the quality of care for its patients, as well as patients worldwide. This is accomplished through objective analysis of current practices and the development of innovative techniques using promising investigational devices and medications within the area of expertise of its ophthalmologists and optometrists.
Major areas of investigation include: refractive surgery, complex case management, cataract surgery, natural lens replacement surgery, glaucoma management, corneal transplantation, iris reconstruction, surgical instrumentation and drug therapies.
Capabilities
Below is a list of capabilities the research department currently provides.
Investigative Site Services
Preclinical & Clinical Consulting
Clinical Trials Management
Conduct IND and IDE studies
Therapeutic opportunity assessments
Documentation development (e.g., protocols, CRFs, consents, advertising and patient education materials)
Conduct federally sponsored studies
Pilot study/early technology assessments
Regulatory submissions
Conduct health outcomes studies
Complex case management
Study budget development and feasibility assessments
Perform specialized ophthalmic tests such as:
Study medical monitoring
Investigative site initiation
Snellen and ETDRS visual acuity
Brightness acuity testing
Contrast sensitivity
Visual fields
Nerve fiber layer analyses
Aberrometry
Corneal topography
Endothelial cell counts
Color vision tests
Pupillometry
Protocol and study design assessments
Internal and external patient recruitment planning
Study planning
Web page development
Process development
Test article accountability methods
Staff Training
Study monitoring
Clinical Research Team Director of Research: David R. Hardten, M.D., F.A.C.S.
Clinical Research Manager: Marlane Brown, O.D., F.A.A.O.
Principal Investigators: Richard L. Lindstrom, M.D., David R. Hardten, M.D., F.A.C.S., Thomas W. Samuelson, M.D., Elizabeth A. Davis, M.D., F.A.C.S. and Patrick J. Riedel, M.D.
Subinvestigators: Sherman W. Reeves, M.D., M.P.H.; Marlane J. Brown, O.D., F.A.A.O.; Scott G. Hauswirth, O.D.;
Ahmad M. Fahmy, O.D.; and Current O.D. and M.D. Fellows
Senior Clinical Research Coordinator: Allison Parent, B.A., CCRC, CCRP
Clinical Research Coordinators: Kate Mercer, B.A., CCRP; Jill Farenbaugh, B.S.; Lindsey DeGoey, B.S., CCRP; Kristal Jones; and Emily Bergeson, B.S.
Clinical Research Assistant: Sara Jenkins, B.S.
Clinical Research Technologist: Jessica Standefer, COMT
Contact the Research Department
For more information, please contact Minnesota Eye Consultants' Clinical Research Department via telephone at (612) 813-3607 or e-mail: research@mneye.com. You can mail to:
9801 Dupont Ave S, Suite 200, Bloomington, MN 55431 OR
710 East 24th Street, Suite 100, Minneapolis, Minnesota 55404.
