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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555165
First Posted: November 7, 2007
Last Update Posted: November 14, 2012
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.
Information provided by (Responsible Party):
VisionCare, Inc.
  Purpose
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 Intervention
End Stage Macular Degeneration Device: Telescope prosthesis

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by VisionCare, Inc.:

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

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

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: Telescope prosthesis
Monocular implantation of the telescope prosthesis after cataract extraction

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT00555165


Locations
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.
Investigators
Principal Investigator: Giuliana Silvestri, MD FRCP FRCS Royal Hospitals, Belfast Health & Social Care Trust
  More Information

Responsible Party: VisionCare, Inc.
ClinicalTrials.gov Identifier: NCT00555165     History of Changes
Other Study ID Numbers: IMT-UK
First Submitted: November 5, 2007
First Posted: November 7, 2007
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