Clinical trial NCT00976235: 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
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Keywords: Macular Degeneration
Visual Impairment
Quality of Life
Telescope Prosthesis
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 129
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
timeFrame: 5 years from implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Centers P.C.
state: Arizona
city: Irvine
country: United States
facility: University of California at Irvine
state: California
city: Los Altos
country: United States
facility: Altos Eye Physician
state: California
city: Los Angeles
country: United States
facility: Doheny Retina Institute - University of Southern California
state: California
city: Sarasota
country: United States
facility: Sarasota Retinal Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Chicago
country: United States
facility: Kraft Eye Institute
state: Illinois
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Baltimore
country: United States
facility: Wilmer Ophthalmological Institute
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye & Ear Infirmary
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: W.K. Kellogg Eye Center
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: New York
country: United States
facility: Manhattan Eye & Ear
state: New York
city: Charlotte
country: United States
facility: Southeast Clinical Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Eugene
country: United States
facility: Fine, Hoffman & Packer
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Vitreoretinal Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: