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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00976235
First received: September 10, 2009
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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 Phase
End Stage Macular Degeneration
 Device: IMT - Implantable Miniature Telescope
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VisionCare Ophthalmic Technologies, 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976235

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

No publications provided

Responsible Party: VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00976235     History of Changes
Other Study ID Numbers: IMT-002-LTM
Study First Received: September 10, 2009
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013