Implantable Miniature Telescope (IMT)

Active Clinical Trials // Feb 14 2017

Sponsored by Vision Care Ophthalmic Technologies

A prospective, multicenter post-approval study (PAS) of Vision Care’s Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in patients with bilateral severe to profound central vision impairment associated with end-stage age-related macular degeneration.

Prinicpal Investigator: Sarah Nehls

Coordinator: Angie Adler

The purpose of the IMT-PAS-01 study is to evaluate the safety of the

intraocular telescope for the treatment of bilateral end-stage age-related

macular degeneration under commercial conditions following U.S. market

approval.

The objective of the study is to assess the safety of the intraocular telescope

as measured by the cumulative incidence of patients who within 5 years

after implantation experience persistent vision-impairing corneal edema

(corneal edema leading to persistent loss of best corrected distance visual

acuity >2 lines from pre-surgery baseline level).

Inclusion Criteria

Patients must:

  • have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography
  • 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 (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.
  • achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
  • have adequate peripheral vision in the eye not scheduled for surgery
  • agree to participate in a postoperative visual training with a low vision specialist.

Please contact the study coordinator with questions: Angie Adler 608-265-7557