Age Related Macular Degeneration
Conditions
Keywords
Macular Degeneration, Visual Impairment, Implantable Telescope
Brief summary
The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
Detailed description
Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol.
Interventions
DEVICEWA-NG (NG-IMT) Telescope Prothesis
The WA-NG telescope prosthesis is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
Sponsors
VisionCare, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*The following Inc. & Exc. are sample and not completed list \*\* Main
Exclusion criteria
* Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement. * Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation * Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS) * Patients must be available for the study duration of 12 months * Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial. Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C) | 12 months | Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test ) |
| Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire | 12 months | Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test ) |
| Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2)) | 12 months | — |
| Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire) | 12 months | Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test ) |
| Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg) | 12 months | Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) |
| Number of Adverse events associated with the implant and use of the device will be evaluated. | 12 months | — |
Countries
Ireland, Spain
Outcome results
None listed