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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Retina Centers P.C., Tucson, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMT - Implantable Miniature Telescope

Device

Implantation of the telescope prosthesis (performed under the initial study)

Primary outcomes

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

Time frame: 5 years from implantation

Sponsors and collaborators

Lead sponsor

VisionCare, Inc.

Industry

Registry information

Official study title

Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Sep 14, 2009
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed