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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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.
Mater Private Hospital
Dublin, Ireland
VISSUM Ophthalmological Corporation
Alicante, Spain
Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
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 )
Time frame: 12 months
Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
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 )
Time frame: 12 months
Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire
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 )
Time frame: 12 months
Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
Time frame: 12 months
Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)
Time frame: 12 months
Number of Adverse events associated with the implant and use of the device will be evaluated.
Time frame: 12 months
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