Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
NCT05438732 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2024-12-03
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).
Conditions
- Age-Related Macular Degeneration
- Geographic Atrophy
Interventions
- DEVICE
-
smaller incision, new generation implantable miniature telescope (SING-IMT)
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
Sponsors & Collaborators
-
ORA, Inc.
collaborator INDUSTRY -
VisionCare, Inc.
lead INDUSTRY
Principal Investigators
-
Rebecca J Kammer, OD, PhD · Samsara Vision Inc.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-16
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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