NCT00555165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

3.5 years

First QC Date

November 5, 2007

Last Update Submit

November 13, 2012

Conditions

End Stage Macular Degeneration

Keywords

Macular DegenerationVisual ImpairmentQuality of LifeImplantable Telescope

Outcome Measures

Primary Outcomes (1)

  • Best-Corrected Visual Acuity

    1 year

Secondary Outcomes (1)

  • Quality of Life

    1 year

Study Arms (1)

I

EXPERIMENTAL
Device: Telescope prosthesis

Interventions

Telescope prosthesisDEVICE

Monocular implantation of the telescope prosthesis after cataract extraction

I

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Frimley Park Hospital NHS Trust

Frimley, Surrey, GU167UJ, United Kingdom

Location

Royal Hospitals, Belfast Health & Social Care Trust

Belfast, BT12 6BA, United Kingdom

Location

Moorfields Eye Hospital NHS Trust

London, EC1V 1JN, United Kingdom

Location

King's College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Macular DegenerationVision Disorders

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giuliana Silvestri, MD FRCP FRCS

    Royal Hospitals, Belfast Health & Social Care Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

GB(4)