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A Long-Term Monitoring Study of the IMT-002 Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976235
First Posted: September 14, 2009
Last Update Posted: November 6, 2017
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
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.

Condition Intervention
Macular Degeneration Device: IMT - Implantable Miniature Telescope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

Resource links provided by NLM:


Further study details as provided by VisionCare, Inc.:

Primary Outcome Measures:
  • Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) [ Time Frame: 5 years from implantation ]

Enrollment: 129
Study Start Date: June 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMT Device: IMT - Implantable Miniature Telescope
Implantation of the telescope prosthesis (performed under the initial study)

Detailed Description:
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
  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:

  • Patients must have participated in the IMT-002 trial.
  • Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
  • Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  • Patients who have not participated in the IMT-002 trial.
  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): NCT00976235


  Show 28 Study Locations
Sponsors and Collaborators
VisionCare, Inc.
  More Information

Responsible Party: VisionCare, Inc.
ClinicalTrials.gov Identifier: NCT00976235     History of Changes
Other Study ID Numbers: IMT-002-LTM
First Submitted: September 10, 2009
First Posted: September 14, 2009
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

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