Post-Approval Study of the Implantable Miniature Telescope

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%.

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Key information

Conditions

AMD

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Eye Center, Chandler, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Miniature Telescope

Device

Device - Implantable Miniature Telescope

Primary outcomes

Long term safety study of implantable miniature telescope

Time frame: 5 years after implantation

Number of persistent vision impairing corneal edema adverse events

Sponsors and collaborators

Lead sponsor

VisionCare, Inc.

Industry

Registry information

Official study title

Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration

Acronym: PAS-01

Important dates

Study start: 2010
Primary completion: 2023
Study completion: 2028
First posted: Dec 28, 2012
Registry last updated: Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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