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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
Monocular implantation of the IMT.
Retinal Consultants of AZ
Phoenix, Arizona, United States
RECRUITINGUC Irvine, Gavin Herbert Eye Institute
Irvine, California, United States
RECRUITINGLoma Linda University Medical Center
Loma Linda, California, United States
RECRUITINGEye Physicians of Long Beach
Long Beach, California, United States
RECRUITINGEye Care of San Diego
San Diego, California, United States
RECRUITINGOrange County Retina
Santa Ana, California, United States
RECRUITINGSarasota Retina Institute
Sarasota, Florida, United States
RECRUITINGUniversity of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
RECRUITINGMinnesota Eye Consultants
Minnetonka, Minnesota, United States
RECRUITINGAssociated Eye Care
Stillwater, Minnesota, United States
RECRUITING...and 4 more locations
Adverse events
All reported adverse events will be summarized by number and percent of occurence.
Time frame: Subjects will be followed up for three years post implantation
Decrease in best corrected distance visual acuity (BCDVA)
Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
Time frame: Subjects will be followed up for three years post implantation
Endothelial Cell Density
ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.
Time frame: Subjects will be followed up for three years post implantation
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