Macular Degeneration
Conditions
Keywords
Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis
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.
Interventions
DEVICEIMT - Implantable Miniature Telescope
Implantation of the telescope prosthesis (performed under the initial study)
Sponsors
VisionCare, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) | 5 years from implantation |
Countries
United States
Outcome results
None listed