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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01757132
First received: November 13, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
AMD
Device: Implantable Miniature Telescope

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by VisionCare Ophthalmic Technologies, Inc.:

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


Estimated Enrollment: 770
Study Start Date: August 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Implantable Miniature Telescope
Post approval study
Device: Implantable Miniature Telescope
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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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.
  • 75 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757132

Locations
United States, California
Retina-Vitreous Associates
Beverly Hills, California, United States, 90211
Loma Linda University Health Care
Loma Linda, California, United States, 92350
United States, Colorado
Specialty Eye CAre (Claucome Consultants of Colorado)
Parker, Colorado, United States, 80134
United States, Florida
Med Eye Associates
Miami, Florida, United States, 33143
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
United States, Georgia
Emory Eye Center
Atlanta, Georgia, United States, 30322
United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
United States, New York
Ophthalmic Consultants Of Long Island
Lynbrook, New York, United States, 11563
New York Eye & Ear
New York, New York, United States, 10003
United States, Oregon
Fine, Hoffman & Packer
Eugene, Oregon, United States, 97401
United States, South Carolina
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States, 29425
United States, Utah
John A. Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
VisionCare Ophthalmic Technologies, Inc.
Investigators
Principal Investigator: Stephen Lane, MD Associated Eye Care
  More Information

No publications provided

Responsible Party: VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01757132     History of Changes
Other Study ID Numbers: PAS-01
Study First Received: November 13, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 18, 2014