A Long-Term Monitoring Study of the IMT-002 Patients
Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
1 other identifier
interventional
129
1 country
28
Brief Summary
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
28 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
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 6, 2017
November 1, 2017
4.9 years
September 10, 2009
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
5 years from implantation
Study Arms (1)
IMT
EXPERIMENTALInterventions
Implantation of the telescope prosthesis (performed under the initial study)
Eligibility Criteria
You may qualify if:
- Patients must have participated in the IMT-002 trial.
- Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
You may not qualify if:
- Patients who have not participated in the IMT-002 trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VisionCare, Inc.lead
Study Sites (28)
Retina Centers P.C.
Tucson, Arizona, 85704, United States
University of California at Irvine
Irvine, California, 92697, United States
Altos Eye Physician
Los Altos, California, 94024, United States
Doheny Retina Institute - University of Southern California
Los Angeles, California, 90033, United States
Sarasota Retinal Institute
Sarasota, Florida, 34239, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Kraft Eye Institute
Chicago, Illinois, 60634, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Wilmer Ophthalmological Institute
Baltimore, Maryland, 21287-9277, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
W.K. Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Associated Eye Care
Stillwater, Minnesota, 55082, United States
Discover Vision Centers
Independence, Missouri, 64055, United States
Manhattan Eye & Ear
New York, New York, 10021, United States
Southeast Clinical Research
Charlotte, North Carolina, 28210, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Retina Associates of Cleveland
Beachwood, Ohio, 44122, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Fine, Hoffman & Packer
Eugene, Oregon, 97401, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Vitreoretinal Foundation
Memphis, Tennessee, 78240, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical Center Ophthalmology
San Antonio, Texas, 78240, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 14, 2009
Study Start
June 1, 2006
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 6, 2017
Record last verified: 2017-11