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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00555165
First received: November 5, 2007
Last updated: November 13, 2012
Last verified: November 2012
  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: 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 Ophthalmic Technologies, Inc.:

Primary Outcome Measures:
  • Best-Corrected Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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: 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 Ophthalmic Technologies, Inc.
Investigators
Principal Investigator: Giuliana Silvestri, MD FRCP FRCS Royal Hospitals, Belfast Health & Social Care Trust
  More Information

No publications provided

Responsible Party: VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00555165     History of Changes
Other Study ID Numbers: IMT-UK
Study First Received: November 5, 2007
Last Updated: November 13, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 24, 2014