Post-Approval Study of the Implantable Miniature Telescope (PAS-01)

VisionCare

Status: Invitation-only

Conditions: AMD

Treatments: Device: Implantable Miniature Telescope

Study type: Interventional

Funder types: Industry

Identifiers

NCT01757132

PAS-01

Details and patient eligibility

About

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level).

The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is >17% against the alternative that the percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is <17%.

Full description

ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.

Enrollment: 770 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
• 65 years of age or older
• retinal findings of geographic atrophy or disciform scar with foveal involvement
• visually significant cataract
• agree to undergo pre- and post-surgery training and assessment
• achieve at least a 5-letter improvement with external telescope
• have adequate peripheral vision in the eye not scheduled for surgery

Exclusion criteria

• Stargardt's macular dystrophy
• Anterior chamber depth < 3.0mm
• Presence of corneal guttate
• Do not meet minimum age and endothelial cell density requirements
• evidence of CNV or treatment of CNV within the past 6 months
• cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
• previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
• history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg while on maximum medication
• known sensitivity to post-operative medications
• history of eye rubbing or an ocular condition that predisposes eye rubbing
• myopia >6.0 D
• hyperopia >4.0D
• axial length <21mm
• narrow angle, i.e., <Schaffer grade 2
• cornea stromal or endothelian dystrophies, including guttate
• inflammatory ocular disease
• zonular weakness/instability of crystalline lens, or pseudoexfoliation
• diabetic retinopathy
• untreated retinal tears
• retinal vascular disease
• optic nerve disease
• history of retinal detachment
• intraocular tumor
• retinitis pigmentosa

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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770 participants in 1 patient group

Implantable Miniature Telescope

Other group

Description:

Post approval study

Treatment:

Device: Implantable Miniature Telescope