A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555165
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : November 14, 2012
Information provided by (Responsible Party):
VisionCare, Inc.

Brief Summary:
Evaluation of pre and post−implantation management of patients with end−stage age−related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.

Condition or disease Intervention/treatment Phase
End Stage Macular Degeneration Device: Telescope prosthesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)
Study Start Date : November 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I Device: Telescope prosthesis
Monocular implantation of the telescope prosthesis after cataract extraction

Primary Outcome Measures :
  1. Best-Corrected Visual Acuity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

CE Mark approved indication of use which includes

  • At least 55 years of age
  • Bilateral visual impairment due to geographic atrophy or disciform scars
  • Evidence of cataract

Exclusion Criteria:

  • Active CNV (or 'wet' AMD)
  • Prior cataract or refractive surgery in the study eye

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 identifier (NCT number): NCT00555165

United Kingdom
Frimley Park Hospital NHS Trust
Frimley, Surrey, United Kingdom, GU167UJ
Royal Hospitals, Belfast Health & Social Care Trust
Belfast, United Kingdom, BT12 6BA
Moorfields Eye Hospital NHS Trust
London, United Kingdom, EC1V 1JN
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
VisionCare, Inc.
Principal Investigator: Giuliana Silvestri, MD FRCP FRCS Royal Hospitals, Belfast Health & Social Care Trust

Responsible Party: VisionCare, Inc. Identifier: NCT00555165     History of Changes
Other Study ID Numbers: IMT-UK
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by VisionCare, Inc.:
Macular Degeneration
Visual Impairment
Quality of Life
Implantable Telescope

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