Actively Recruiting
Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
Led by VisionCare, Inc. · Updated on 2024-12-03
125
Participants Needed
10
Research Sites
180 weeks
Total Duration
On this page
Sponsors
V
VisionCare, Inc.
Lead Sponsor
O
ORA, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 65 years old at the pre-operative visit
- Have bilateral central vision loss with ETDRS best-corrected distance visual acuity (BCDVA) between 0.9 to 1.6 logMAR (20/160 to 20/800) caused by end-stage AMD
- Have retinal findings of geographic atrophy or disciform scar involving the fovea confirmed by fluorescein angiography
- Have been monitored by an eye care provider for at least 6 months without evidence of active choroidal neovascularization
- Agree to participate in post-operative visual training
- Have visually significant cataract in the implanted eye
- Complete pre-operative training with a low vision specialist and show at least 5-letter visual acuity improvement with an external telescope
- Have adequate peripheral vision in the non-implanted eye to allow navigation
You will not qualify if you...
- Cognitive impairment that interferes with informed consent or visual training
- Presence of Stargardt macular dystrophy, diabetic retinopathy, untreated retinal tears, retinal vascular disease, optic nerve disease, history of retinal detachment, intraocular tumor, or retinitis pigmentosa
- History of steroid-induced intraocular pressure rise, uncontrolled glaucoma, or intraocular pressure over 22 mmHg
- Known allergy to post-operative medications
- History of eye rubbing or conditions predisposing to eye rubbing
- Prior or expected ophthalmic surgery within 30 days before surgery
- Any condition posing safety concerns as judged by the investigator
- Systemic disease or clinical condition deemed unsuitable by the investigator
- Participation in any investigational drug or device study within 30 days before pre-operative visit
- Central anterior chamber depth less than 3.0 mm in the implanted eye
- Low endothelial cell density below age-specific thresholds
- History of corneal dystrophies including guttata
- Myopia greater than 6.0 diopters or hyperopia greater than 4.0 diopters
- Axial length less than 21 mm
- Narrow angle less than grade 2 on Schaffer scale
- Ongoing inflammatory ocular disease
- Zonular weakness or pseudoexfoliation
- Conditions preventing proper implant placement during surgery
- Previous intraocular or corneal surgery including refractive or therapeutic procedures
- Ophthalmic pathology in the non-implanted eye that compromises peripheral vision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
2
Eye Physicians of Long Beach
Long Beach, California, United States, 90815
Actively Recruiting
3
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
4
Tallman Eye Associates
Lawrence, Massachusetts, United States, 01841
Actively Recruiting
5
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States, 48009
Actively Recruiting
6
Vance Thompson Vision
Omaha, Nebraska, United States, 68137
Actively Recruiting
7
Atlantic Eye Physicians
Eatontown, New Jersey, United States, 07724
Actively Recruiting
8
Western Carolina Retinal Associates
Asheville, North Carolina, United States, 28803
Actively Recruiting
9
Cleveland Clinic | Cole Eye Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Methodist Eye Associates | Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Rebecca Kammer, OD, PhD
CONTACT
C
Colleen Collier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here