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

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ClinicalTrials.gov Identifier: NCT01757132
Recruitment Status : Enrolling by invitation
First Posted : December 28, 2012
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
VisionCare, Inc.

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%.


Condition or disease Intervention/treatment Phase
AMD Device: Implantable Miniature Telescope Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 770 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Study Start Date : August 2010
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Implantable Miniature Telescope
Post approval study
Device: Implantable Miniature Telescope
Device - Implantable Miniature Telescope




Primary Outcome Measures :
  1. Long term safety study of implantable miniature telescope [ Time Frame: 5 years after implantation ]
    Number of persistent vision impairing corneal edema adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757132


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

Responsible Party: VisionCare, Inc.
ClinicalTrials.gov Identifier: NCT01757132     History of Changes
Other Study ID Numbers: PAS-01
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018