The IMT has a Galilean design, based on wide-angle micro-optics that, in combination with the optics of the cornea, create a telephoto system that magnifies objects in view. Implantation inside the eye allows the patient to see using natural eye movements in both stationary and dynamic environments.
The telescope is about the size of a pea (3.6 mm ; 4.4 mm length) and is surgically placed inside the eye.
The Intraocular Telescope is surgically implanted monocularly in the capsular bag after removal of the eye’s lens and is held in position by haptic loops. The telescope implant, along with the cornea, enlarges images in front of the eye approximately 2.2 or 2.7 times their normal size, depending on the model used. The nominal field of view of 20° is projected onto approximately 54° of the retina, effectively reducing the impact of the central scotoma (blind spot) in central vision. The magnification allows central images to be projected onto healthy perimacular areas of the retina instead of the macula alone where breakdown of photoreceptors and loss of vision has occurred.
This helps reduce the ‘blind spot’ and allows the patient to distinguish and discern images that may have been unrecognizable or difficult to see due to the central scotoma associated with their AMD. The central scotoma is not eliminated or cured, but patients can better see “around” it as images are projected onto healthier parts of retina undamaged by AMD.
The IMT is housed in a prosthetic device (refer to professional use information) composed of three primary components: a glass capsule that contains wide-angle micro-optical elements; a clear polymethylmethacrylate (PMMA) carrier; and a blue PMMA light restrictor. The sealed optical component is snap-fitted into the carrier plate.
The IMT is available in two telescope prosthesis models: Wide Angle (WA) 2.2X and Wide Angle (WA) 2.7X. Both models are FDA approved for monocular implantation to improve vision in patients ≥ 65 years of age with stable severe to profound (distance BCVA of 20/160 to 20/800) vision impairment caused by bilateral central scotomas associated with End-Stage AMD. The implanted eye provides central vision, while the fellow eye continues to be used for peripheral vision.
The telescope prosthesis uses biocompatible materials for long-term ocular implantation per ISO 10993-1. One of the internal components (not in contact with body fluids or tissue) of the device contains stainless steel, which has been evaluated for MRI compatibility and determined to be MR-Conditional.*
*MRI testing was performed to evaluate the magnetic field interactions, heating, and artifacts of the telescope prosthesis induced by a commercial 3-Tesla MRI system. Based on the MRI testing information, the telescope prosthesis will not present any additional hazard or risk to a patient undergoing an MRI procedure using a scanner operating with a static magnetic field of 3-Tesla or less and under the MRI-related heating conditions used for the evaluation (MRI for 15 minutes at an MR system reported whole body averaged specific absorption rate, SAR, value of 3 W/Kg). The MRI image quality may be compromised if the area of interest is the same as or close to the position of the device (in this case, it may be necessary to optimize MR imaging parameters to compensate for the presence of the implant).
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