A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-related Macular Degeneration
- Sponsor
- VisionCare, Inc.
- Enrollment
- 75
- Locations
- 14
- Primary Endpoint
- Adverse events
- Last Updated
- 8 years ago
Overview
Brief Summary
VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD).
Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are currently contraindicated for telescope surgery.
These patients have no viable therapy available to improve their vision.
The objective of the TES pilot study is to evaluate the safety and effectiveness of implanting the intraocular telescope for improving vision in patients with bilateral end-stage age- related macular degeneration who are pseudophakic.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by FA
- •Be age 65 or older
- •Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart
- •Be pseudophakic in the eye selected for telescope implantation
- •Agree to undergo pre-surgery training with a low vision specialist
- •Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
- •Agree to participate in postoperative vision training with a low vision specialist.
- •Patients must be able to provide and sign a voluntary informed consent.
- •Patients must not meet any of the exclusion criteria below.
Exclusion Criteria
- •Stargardt's macular dystrophy
- •Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device.
- •Any ophthalmic pathology that compromises fellow-eye peripheral vision
- •A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP \>22mmHg while on maximum medication
- •Known sensitivity to planned study concomitant medications.
- •An ocular condition that predisposes the patient to eye rubbing.
- •Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- •Operative eye with:
- •Evidence of active CNV or treatment of CNV within 6 months
- •IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.
Outcomes
Primary Outcomes
Adverse events
Time Frame: Subjects will be followed up for three years post implantation
All reported adverse events will be summarized by number and percent of occurence.
Secondary Outcomes
- Decrease in best corrected distance visual acuity (BCDVA)(Subjects will be followed up for three years post implantation)
- Endothelial Cell Density(Subjects will be followed up for three years post implantation)