A Long-Term Monitoring Study of the IMT-002 Patients
- Conditions
- Macular Degeneration
- Interventions
- Device: IMT - Implantable Miniature Telescope
- Registration Number
- NCT00976235
- Lead Sponsor
- VisionCare, Inc.
- 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.
- Detailed Description
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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.
- Patients who have not participated in the IMT-002 trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMT IMT - Implantable Miniature Telescope -
- Primary Outcome Measures
Name Time Method Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) 5 years from implantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
University of California at Irvine
🇺🇸Irvine, California, United States
Wilmer Ophthalmological Institute
🇺🇸Baltimore, Maryland, United States
Sarasota Retinal Institute
🇺🇸Sarasota, Florida, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
Associated Eye Care
🇺🇸Stillwater, Minnesota, United States
Doheny Retina Institute - University of Southern California
🇺🇸Los Angeles, California, United States
Altos Eye Physician
🇺🇸Los Altos, California, United States
Retina Centers P.C.
🇺🇸Tucson, Arizona, United States
Manhattan Eye & Ear
🇺🇸New York, New York, United States
Massachusetts Eye & Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Kraft Eye Institute
🇺🇸Chicago, Illinois, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Medical Center Ophthalmology
🇺🇸San Antonio, Texas, United States
Fine, Hoffman & Packer
🇺🇸Eugene, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Discover Vision Centers
🇺🇸Independence, Missouri, United States
Retina Associates of Cleveland
🇺🇸Beachwood, Ohio, United States
Southeast Clinical Research
🇺🇸Charlotte, North Carolina, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Vitreoretinal Foundation
🇺🇸Memphis, Tennessee, United States
W.K. Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States