STUDY OF VISIONCARE'S MINIATURE IMPLANTABLE TELESCOPE
|Principal Investigator: MarkMifflin|
|Keywords: telescope , AMD||Department: Ophthalmology-Services|
|IRB Number: 00052301||Co Investigator: AlbertVitale|
As a condition of approval of the intraocular telescope, CDRH requests a post-approval study to evaluate the safety of the telescope when used under commercial conditions. The purpose of this study is to evaluate the safety of the intraocular telescope for the treatment of bilateral end-stage age-related macular degeneration. Over five years, the study will evaluate the incidence of adverse events associated with use of the intraocular telescope as a marketed product.
• have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography
• have evidence of visually significant cataract (≥ Grade 2)
• agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.
• achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
• have adequate peripheral vision in the eye not scheduled for surgery
• agree to participate in a postoperative visual training with a low vision specialist.
Implantation of the intraocular telescope is contraindicated in patients:
• with Stargardt’s macular dystrophy
• with central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens.
• with the presence of corneal guttata
• who do not meet the minimum age and endothelial cell density requirements. Patients in the age range of 76 – 84 years must have a minimum cell density of 2000 cell/mm2. Patients age 85 years old or older must have a minimum cell density of 1800 cell/mm2.
The device is also contraindicated in patients:
• with cognitive impairment that would interfere with the ability to understand and complete the Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation with the device
• who have evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months
• with any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye
• with previous intraocular or cornea surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes
• who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
• with a history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg, while on maximum medication
• with known sensitivity to post-operative medications
• who have a history of eye rubbing or an ocular condition that predisposes them to eye rubbing
• in whom the planned operative eye has:
– Myopia > 6.0 D
– Hyperopia > 4.0 D
– An axial length < 21 mm
– A narrow angle, i.e., < Schaffer grade 2
– Cornea stromal or endothelial dystrophies, including guttata
– Inflammatory ocular disease
– Zonular weakness/instability of crystalline lens, or pseudoexfoliation
– Diabetic retinopathy
– Untreated retinal tears
– Retinal vascular disease
– Optic nerve disease
– A history of retinal detachment
– Intraocular tumor
– Retinitis pigmentosa