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

NCT ID: NCT00555165

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Macular Degeneration

Keywords

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Macular Degeneration Visual Impairment Quality of Life Implantable Telescope

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Group Type EXPERIMENTAL

Telescope prosthesis

Intervention Type DEVICE

Monocular implantation of the telescope prosthesis after cataract extraction

Interventions

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Telescope prosthesis

Monocular implantation of the telescope prosthesis after cataract extraction

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VisionCare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuliana Silvestri, MD FRCP FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Hospitals, Belfast Health & Social Care Trust

Locations

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Frimley Park Hospital NHS Trust

Frimley, Surrey, United Kingdom

Site Status

Royal Hospitals, Belfast Health & Social Care Trust

Belfast, , United Kingdom

Site Status

Moorfields Eye Hospital NHS Trust

London, , United Kingdom

Site Status

King's College Hospital NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IMT-UK

Identifier Type: -

Identifier Source: org_study_id