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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- VisionCare, Inc.
- Enrollment
- 125
- Locations
- 10
- Primary Endpoint
- Primary Effectiveness Outcome
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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).
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
- •Have any of the following conditions at the Pre-operative Visit:
- •Stargardt macular dystrophy;
- •Diabetic retinopathy;
- •Untreated retinal tears;
- •Retinal vascular disease;
- •Optic nerve disease;
- •History of retinal detachment;
- •Intraocular tumor;
- •Retinitis pigmentosa;
Outcomes
Primary Outcomes
Primary Effectiveness Outcome
Time Frame: Approximately 12-months post-operatively (330-420 days)
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
Primary Safety Outcome
Time Frame: Approximately 12-months post-operatively (330-420 days)
Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)
Secondary Outcomes
- Best-corrected distance visual acuity (BCDVA)(Approximately 12-months post-operatively (330-420 days))
- Best-corrected near visual acuity (BCNVA)(Approximately 12-months post-operatively (330-420 days))
- IMT position(Approximately 12-months post-operatively (330-420 days))
- Posterior Capsule Opacification(Approximately 12-months post-operatively (330-420 days))
- Anterior Chamber Depth(Approximately 12-months post-operatively (330-420 days))
- Adverse Events(Approximately 12-months post-operatively (330-420 days))