This document addresses intraocular telescope devices (for example, the Implantable Miniature Telescope^™ [IMT] [Samsara Vision, Inc., Far Hills, NJ]). The IMT is used to improve certain cases of severe to profound vision impairment caused by end-stage, age-related macular degeneration (AMD).

Clinical Indications

Medically Necessary:

An intraocular telescope (for example, the Implantable Miniature Telescope) is considered medically necessary for monocular implantation to improve vision in individuals 65 years of age or older when all of the following criteria are met:

The individual must:

• Achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study chart with an external telescope in the eye scheduled for surgery; and
• Agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for assessment and for the individual to make an informed decision; and
• Agree to participate in postoperative visual training with a low vision specialist; and
• Have adequate peripheral vision in the eye not scheduled for surgery; and
• Have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography; and
• Have stable, severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas, associated with end-stage age-related macular degeneration; and
• Show evidence of visually significant cataract (Grade 2 or more).

Not Medically Necessary:

An intraocular telescope (for example, the Implantable Miniature Telescope) is considered not medically necessary when all of the above criteria are not met.