The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
125
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
Loma Linda University
Loma Linda, California, United States
RECRUITINGEye Physicians of Long Beach
Long Beach, California, United States
RECRUITINGPrimary Effectiveness Outcome
Proportion of study eyes with an improvement of 10 or more ETDRS letters (0.2 logMAR) in either BCDVA or BCNVA at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame: Approximately 12-months post-operatively (330-420 days)
Primary Safety Outcome
Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)
Time frame: Approximately 12-months post-operatively (330-420 days)
Best-corrected distance visual acuity (BCDVA)
Post-operative BCDVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame: Approximately 12-months post-operatively (330-420 days)
Best-corrected near visual acuity (BCNVA)
Post-operative BCNVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame: Approximately 12-months post-operatively (330-420 days)
Anterior Chamber Depth
Anterior Chamber Depth in study eyes, defined as the distance between the corneal endothelium and the front surface of the IMT, at Visit 5 (330 to 420 days post-operatively)
Time frame: Approximately 12-months post-operatively (330-420 days)
IMT position
IMT tilt and centration in study eyes at Visit 5 (330 to 420 days post-operatively)
Time frame: Approximately 12-months post-operatively (330-420 days)
Adverse Events
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Sarasota Retina Institute
Sarasota, Florida, United States
RECRUITINGTallman Eye Associates
Lawrence, Massachusetts, United States
RECRUITINGOakland Ophthalmic Surgery
Birmingham, Michigan, United States
RECRUITINGVance Thompson Vision
Omaha, Nebraska, United States
RECRUITINGAtlantic Eye Physicians
Eatontown, New Jersey, United States
RECRUITINGWestern Carolina Retinal Associates
Asheville, North Carolina, United States
RECRUITINGCleveland Clinic | Cole Eye Institute
Cleveland, Ohio, United States
RECRUITINGMethodist Eye Associates | Houston Methodist
Houston, Texas, United States
RECRUITINGRates of adverse events from Operative Visit through Visit 5 (330 to 420 days post-operatively)
Time frame: Approximately 12-months post-operatively (330-420 days)
Posterior Capsule Opacification
Rates of posterior capsule opacification in study eyes at post-operative visit 5 (330 to 420 days post-operatively)
Time frame: Approximately 12-months post-operatively (330-420 days)