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
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).
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