Summary Of Evidence

N/A

Analysis of Evidence

N/A

Abstract:

The Implantable Miniature Telescope (IMT) is a telescope prosthetic device that replaces the natural lens in one eye of patients with bilateral, advanced age-related macular degeneration in order to enlarge the retinal image to such a degree that it is visualized outside of vision-impairing central scotomas.

After review of available peer-reviewed literature, National Government Services has determined that appropriate utilization of the IMT in patients who meet all of the indications detailed below may be payable by Medicare.

Indications:

The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotoma associated with untreatable end-stage age-related macular degeneration.

Patients must:

• Have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography
• Have untreatable end-stage, non-exudative, age-related macular degeneration
• Have evidence of visually significant cataract (= Grade 2)
• Agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision regarding the potential risks and benefits of the IMT
• Achieve at least 5-letter improvement on the ETDRS chart with an external telescope during the pre-implant evaluation
• Have adequate peripheral vision in the eye not scheduled for surgery
• Complete and agree to the “Acceptance of risk and informed consent agreement” provided in the device labeling documentation
• Agree to participate in post-implant visual training with a low vision specialist

Limitations:

Implantation of the intraocular telescope is contraindicated in patients:

• with Stargardt’s macular dystrophy
• with central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens
• with the presence of corneal guttata
• who do not meet the minimum age and endothelial cell density requirements (age 65 to < 70 min. cell density = 2300 cells/mm²; age 70 to < 75 min. cell density = 2000 cells/mm²; age 75 or greater min. cell density = 1800 cells/mm²)
• with cognitive impairment that would interfere with the ability to understand and complete the Acceptance of Risk and Informed Decision Agreement or prevent proper visual training/rehabilitation with the device
• who have evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months
• with any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye
• with previous intraocular or cornea surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes
• who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope implantation
• with a history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP > 22 mm Hg, while on maximum medication
• with known sensitivity to post-operative medications
• who have a history of eye rubbing or an ocular condition that predisposes them to eye rubbing
• in whom the planned operative eye has:
  o Myopia > 6.0 D, Hyperopia > 4.0 D
  o Axial length < 21 mm
  o A narrow angle, i.e., < Schaffer grade 2
  o Cornea stromal or endothelial dystrophies, including guttata
  o Inflammatory ocular disease
  o Zonular weakness/instability of crystalline lens, or pseudoexfoliation
  o Diabetic retinopathy, untreated retinal tears, retinal vascular disease, history of retinal detachment, retinitis pigmentosa
  o Intraocular tumor
  o Optic nerve disease
• In eyes in which both haptics cannot be placed within the capsular bag during surgery, the intraocular telescope should be removed and replaced with a conventional intraocular lens (IOL); sulcus fixation of either one or both haptics increases the risk of severe endothelial cell loss and corneal transplant
• actively wet age-related macular degeneration (ARMD)

Other Comments:

The U.S. Food and Drug Administration (FDA) labeling specifies that a cornea specialist perform the IMT, because they are the ophthalmic surgical specialty with the additional surgical training required for advanced corneal procedures such as cornea transplants.

Prior to performing IMT, surgeons must participate in the required portion of the Physician Training Program provided by the device manufacturer.

National Government Services expects adequate follow-up of these patients (to include post-operative follow-up and rehabilitation services) to assure the best possible results for these patients. National Government Services anticipates this may require both short-term and long-term record review.