Post-Approval Study of the Implantable Miniature Telescope

NCT ID: NCT01757132

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2028-12-31

Brief Summary

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%.

Detailed 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.

Conditions

AMD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implantable Miniature Telescope

Post approval study

Group Type: OTHER

Implantable Miniature Telescope

Intervention Type: DEVICE

Device - Implantable Miniature Telescope

Interventions

Implantable Miniature Telescope

Device - Implantable Miniature Telescope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VisionCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver D Schein, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Arizona Eye Center

Chandler, Arizona, United States

Retinal Consultants of Arizona, LTD

Phoenix, Arizona, United States

Barnet, Dulaney, Perkins Eye

Phoenix, Arizona, United States

Retina-Vitreous Associates

Beverly Hills, California, United States

Retina Consultants of Orange County

Fullerton, California, United States

Loma Linda University Health Care

Loma Linda, California, United States

University of California - Davis

Sacramento, California, United States

Specialty Eye Care (Glaucoma Consultants of Colorado)

Parker, Colorado, United States

Retina Speciality Institute

Pensacola, Florida, United States

Sarasota Retinal Institute

Sarasota, Florida, United States

Emory Eye Center

Atlanta, Georgia, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Pepose Vision Institute

Chesterfield, Missouri, United States

New York Eye & Ear

New York, New York, United States

Fine, Hoffman & Packer

Eugene, Oregon, United States

Valley Retina Institute

McAllen, Texas, United States

Countries

United States

Other Identifiers

PAS-01

Identifier Type: -

Identifier Source: org_study_id