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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMT - Implantable Miniature Telescope
Sponsored by
VisionCare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Macular Degeneration focused on measuring Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Centers P.C.
  • University of California at Irvine
  • Altos Eye Physician
  • Doheny Retina Institute - University of Southern California
  • Sarasota Retinal Institute
  • Emory Eye Center
  • Kraft Eye Institute
  • Paducah Retinal Center
  • Wilmer Ophthalmological Institute
  • Retina Group of Washington
  • Massachusetts Eye & Ear Infirmary
  • Ophthalmic Consultants of Boston
  • W.K. Kellogg Eye Center
  • Associated Retinal Consultants
  • Associated Eye Care
  • Discover Vision Centers
  • Manhattan Eye & Ear
  • Southeast Clinical Research
  • Duke University Eye Center
  • Retina Associates of Cleveland
  • Dean A. McGee Eye Institute
  • Fine, Hoffman & Packer
  • Wills Eye Hospital
  • Vitreoretinal Foundation
  • Vanderbilt University
  • Baylor College of Medicine
  • Medical Center Ophthalmology
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMT

Arm Description

Outcomes

Primary Outcome Measures

Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)

Secondary Outcome Measures

Full Information

First Posted
September 10, 2009
Last Updated
November 1, 2017
Sponsor
VisionCare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00976235
Brief Title
A Long-Term Monitoring Study of the IMT-002 Patients
Official Title
Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionCare, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IMT - Implantable Miniature Telescope
Intervention Description
Implantation of the telescope prosthesis (performed under the initial study)
Primary Outcome Measure Information:
Title
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
Time Frame
5 years from implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Retina Centers P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of California at Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Altos Eye Physician
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
Doheny Retina Institute - University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Sarasota Retinal Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kraft Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Wilmer Ophthalmological Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9277
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
W.K. Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Associated Retinal Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Manhattan Eye & Ear
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Southeast Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Retina Associates of Cleveland
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Fine, Hoffman & Packer
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vitreoretinal Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
78240
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Center Ophthalmology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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