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VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD).
Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are currently contraindicated for telescope surgery.
These patients have no viable therapy available to improve their vision.
The objective of the TES pilot study is to evaluate the safety and effectiveness of implanting the intraocular telescope for improving vision in patients with bilateral end-stage age- related macular degeneration who are pseudophakic.
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Inclusion criteria
Exclusion criteria
Stargardt's macular dystrophy
Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device.
Any ophthalmic pathology that compromises fellow-eye peripheral vision
A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP >22mmHg while on maximum medication
Known sensitivity to planned study concomitant medications.
An ocular condition that predisposes the patient to eye rubbing.
Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Operative eye with:
Primary purpose
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Interventional model
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75 participants in 1 patient group
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Central trial contact
Diane Gordon; Carole Schreier
Data sourced from clinicaltrials.gov
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