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PAS-01: Post-Approval Study of the Implantable Miniature Telescope

Sponsor
VisionCare, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01757132
Collaborator
(none)
770
Enrollment
16
Locations
1
Arm
220
Duration (Months)
48.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Implantable Miniature Telescope
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
770 participants
Allocation:
N/A
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 :
Aug 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Other: Implantable Miniature Telescope

Post approval study

Device: Implantable Miniature Telescope
Device - Implantable Miniature Telescope

Outcome Measures

Primary Outcome Measures

  1. Long term safety study of implantable miniature telescope [5 years after implantation]

    Number of persistent vision impairing corneal edema adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Eye Center Chandler Arizona United States 85225
2 Retinal Consultants of Arizona, LTD Phoenix Arizona United States 85014
3 Barnet, Dulaney, Perkins Eye Phoenix Arizona United States 85016
4 Retina-Vitreous Associates Beverly Hills California United States 90211
5 Retina Consultants of Orange County Fullerton California United States 92835
6 Loma Linda University Health Care Loma Linda California United States 92350
7 University of California - Davis Sacramento California United States 95817
8 Specialty Eye Care (Glaucoma Consultants of Colorado) Parker Colorado United States 80134
9 Retina Speciality Institute Pensacola Florida United States 32503
10 Sarasota Retinal Institute Sarasota Florida United States 34239
11 Emory Eye Center Atlanta Georgia United States 30322
12 University of Michigan, Kellogg Eye Center Ann Arbor Michigan United States 48105
13 Pepose Vision Institute Chesterfield Missouri United States 63017
14 New York Eye & Ear New York New York United States 10003
15 Fine, Hoffman & Packer Eugene Oregon United States 97401
16 Valley Retina Institute McAllen Texas United States 78503

Sponsors and Collaborators

  • VisionCare, Inc.

Investigators

  • Principal Investigator: Oliver D Schein, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VisionCare, Inc.
ClinicalTrials.gov Identifier:
NCT01757132
Other Study ID Numbers:
  • PAS-01
First Posted:
Dec 28, 2012
Last Update Posted:
Nov 16, 2018
Last Verified:
Nov 1, 2018

Study Results

No Results Posted as of Nov 16, 2018