A Study of an Implantable Miniature Telescope in Patients... | NCT00555165

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

NCT00555165

Sponsor

VisionCare, Inc.

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

End Stage Macular Degeneration

Interventions

Telescope prosthesis

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Nov 5, 2007

First Submission Date that Met QC Criteria

Nov 5, 2007

First Posted Date

Nov 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental		Device: Telescope prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telescope prosthesis	Device	Monocular implantation of the telescope prosthesis after cataract extraction	I

Measure	Description	Time Frame
Best-Corrected Visual Acuity		1 year

Measure	Description	Time Frame
Quality of Life		1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuliana Silvestri, MD FRCP FRCS	Royal Hospitals, Belfast Health & Social Care Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frimley Park Hospital NHS Trust		Frimley	Surrey	GU167UJ	United Kingdom
Royal Hospitals, Belfast Health & Social Care Trust

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D014786	Vision Disorders

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided