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
  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:


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
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: 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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014