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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.
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMT - Implantable Miniature Telescope | Device | Implantation of the telescope prosthesis (performed under the initial study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) | 5 years from implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Centers P.C. | Tucson | Arizona | 85704 | United States | ||
| University of California at Irvine |
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| 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 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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