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

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

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%.

Study Overview

• Status: Enrolling by invitation
• Conditions: AMD
• Intervention / Treatment: Device: Implantable Miniature Telescope

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.

• Study Type: Interventional
• Enrollment (Anticipated): 770
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Eye Center
    • Phoenix, Arizona, United States, 85014
      • Retinal Consultants of Arizona, LTD
    • Phoenix, Arizona, United States, 85016
      • Barnet, Dulaney, Perkins Eye
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Loma Linda, California, United States, 92350
      • Loma Linda University Health Care
    • Sacramento, California, United States, 95817
      • University of California - Davis
  • Colorado
    • Parker, Colorado, United States, 80134
      • Specialty Eye Care (Glaucoma Consultants of Colorado)
  • Florida
    • Pensacola, Florida, United States, 32503
      • Retina Speciality Institute
    • Sarasota, Florida, United States, 34239
      • Sarasota Retinal Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Eye Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan, Kellogg Eye Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute
  • New York
    • New York, New York, United States, 10003
      • New York Eye & Ear
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Fine, Hoffman & Packer
  • Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implantable Miniature Telescope; Post approval study	Device: Implantable Miniature Telescope; Device - Implantable Miniature Telescope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term safety study of implantable miniature telescope	Number of persistent vision impairing corneal edema adverse events	5 years after implantation

Collaborators and Investigators

• Sponsor: VisionCare, Inc.
• Investigators: Principal Investigator: Oliver D Schein, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 28, 2012

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PAS-01