A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.

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Key information

Conditions

End Stage Macular Degeneration Eye Diseases Macular Degeneration 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

Frimley Park Hospital NHS Trust, Frimley, Surrey, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

CE Mark approved indication of use which includes

At least 55 years of age
Bilateral visual impairment due to geographic atrophy or disciform scars
Evidence of cataract

Exclusion criteria

Active CNV (or 'wet' AMD)
Prior cataract or refractive surgery in the study eye

Treatment and study plan

Telescope prosthesis

Device

Monocular implantation of the telescope prosthesis after cataract extraction

Primary outcomes

Best-Corrected Visual Acuity

Time frame: 1 year

Secondary outcomes

Quality of Life

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

VisionCare, Inc.

Industry

Registry information

Official study title

A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Nov 7, 2007
Registry last updated: Nov 14, 2012

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.

Published trials that share one or more normalized conditions with this study.

Completed