A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Be at least 65 years of age at the Pre-operative Visit;

• Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;

• Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;

• Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:

‣ lack of need of treatment for CNV over the past 6 months, and

⁃ lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and

⁃ lack of Retinal hemorrhage on exam over a 6-month period or longer

• Agree to participate in post-operative visual training

• For the Implanted Eye:

• Have evidence of visually significant cataract at the Pre-operative Visit;

• Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment

• For the Non-Implanted Eye:

• Have adequate peripheral vision at the Pre-operative Visit to allow navigation

Locations
United States
California
Loma Linda University
RECRUITING
Loma Linda
Eye Physicians of Long Beach
RECRUITING
Long Beach
Florida
Sarasota Retina Institute
RECRUITING
Sarasota
Massachusetts
Tallman Eye Associates
RECRUITING
Lawrence
Michigan
Oakland Ophthalmic Surgery
RECRUITING
Birmingham
North Carolina
Western Carolina Retinal Associates
RECRUITING
Asheville
Nebraska
Vance Thompson Vision
RECRUITING
Omaha
New Jersey
Atlantic Eye Physicians
RECRUITING
Eatontown
Ohio
Cleveland Clinic | Cole Eye Institute
RECRUITING
Cleveland
Texas
Methodist Eye Associates | Houston Methodist
RECRUITING
Houston
Contact Information
Primary
Rebecca Kammer, OD, PhD
rkammer@samsaravision.com
+1 (714) 728-1575
Backup
Colleen Collier
ccollier@samsaravision.com
+1 (609) 213-9420
Time Frame
Start Date: 2022-06-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 125
Treatments
Experimental: SING-IMT Implanted
the implanted eye will be the study eye which receives the SING-IMT. Implantation will occur during routine cataract surgery using a proprietary delivery system (loading cartridge and injector), via an approximately 6.5mm incision
Sponsors
Leads: VisionCare, Inc.
Collaborators: ORA, Inc.

This content was sourced from clinicaltrials.gov