NCT00971464

Brief Summary

Patients with advanced Age-Related Macular Degeneration will be randomized into one of two treatment groups. One group will receive eccentric view (EV) training while the other a closed circuit television (CCTV) training for 6 weeks. Reading speed and accuracy will be assessed pre- and post- treatment to determine if one treatment is superior to the other.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 2, 2009

Last Update Submit

September 7, 2012

Conditions

AMD

Keywords

AMDEVCCTVReadingvision

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures reading speed for 1.3M print (in correct words per minute).

    6 weeks intervention

Secondary Outcomes (6)

  • The secondary outcomes measures 1. Reading accuracy for 1.3M;

    6 weeks intervention

  • 2. Reading speed and accuracy for 1M

    6 weeks intervention

  • 3. Reading performance tests.

    6 week's intervention

  • 4. Reading Behavior Inventory

    6 week's intervention

  • 5. VFQ-25 plus 2 extra questions).

    6 week's intervention

  • +1 more secondary outcomes

Study Arms (2)

Eccentric viewing

EXPERIMENTAL

Eccentric viewing is the use of a retinal locus other than the anatomical fovea for fixation in cases when there is central vision loss. This other area (or areas) is called the preferred retinal locus (PRL). In eccentric viewing the patient is aware that they are "looking to the side" or "using their side vision". Most patients with a dense central scotoma will develop eccentric viewing naturally over time. It is thought, however, that, in many cases the naturally developed PRL is not in the ideal position. The four components of eccentric viewing that will be taught are: 1) The optimal direction for eccentric viewing 2) Using large objects to teach eccentric viewing 3) Repetitive practicing of the technique and 4) Maintaining the eye in the eccentric viewing position.

Behavioral: eccentric viewing (EV) training

CCTV arm

ACTIVE COMPARATOR

A CCTV is an electro-optical device mainly used for reading, but which can also be used for writing or viewing pictures. It is comprised of a video camera which faces downwards towards the reading material and which inputs the image to a digital monitor. Magnification is variable over a large range. By means of a zoom lens and the brightness, contrast, and image polarity (black letters on white or white on black) can be controlled to provide the best combination of viewing conditions for an individual user. The significant advantages of CCTV over optical magnifiers are that it provides high levels of magnification with a greater field of view (compared to the equivalent optical device), allows reading at a more normal viewing distance of about 40 - 50 cms and allows binocular viewing.

Device: Closed circuit television (CCTV)

Interventions

eccentric viewing (EV) trainingBEHAVIORAL

Eccentric viewing training for 6 weeks, minimum two 10 minutes per day.

Also known as: eccentric fixation training, vision training
Eccentric viewing
Closed circuit television (CCTV)DEVICE

A CCTV is an electro-optical device mainly used for reading.

Also known as: EVES, electronic vision enhancement system
CCTV arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First time AMD patient sent to CNIB for visual rehabilitation
  • Macular Degeneration reducing visual acuity (VA) to between 20/160 and 20/400 (ETDRS scale)
  • Over the age of 50 years
  • English as the first language and able to read

You may not qualify if:

  • Expected anti-VEGF or Visudyne treatment over the course of the study
  • Individuals who do not have reading as a life goal
  • Mental cognition that makes learning the specific rehabilitation tasks unlikely (determined by mini-mental state exam)
  • Any other ocular pathology that can reduce central vision including cornea decompensation (scar or thickness), cataract (grade III or more for each type of cataract), vitritis (2+ or more) or advanced glaucoma (C/D ratio of \>0.7)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNIB, Toronto Branch

Toronto, Ontario, M4G 3E8, Canada

Location

Study Officials

  • William Hodge, MD, PhD

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

CA(1)