A Long-Term Monitoring Study of the IMT-002 Patients
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 11/8/2017 |
| Start Date: | June 2006 |
| End Date: | May 2011 |
Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
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.
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.
examination, endothelial cell density, device failures, complications and adverse events will
be assessed.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have not participated in the IMT-002 trial.
We found this trial at
28
sites
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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