Low Vision Study Comparing EV Training vs. CCTV for AMD Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Hodge, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00971464
First received: September 2, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
AMD
Behavioral: eccentric viewing (EV) training
Device: Closed circuit television (CCTV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • The primary outcome measures reading speed for 1.3M print (in correct words per minute). [ Time Frame: 6 weeks intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcomes measures 1. Reading accuracy for 1.3M; [ Time Frame: 6 weeks intervention ] [ Designated as safety issue: No ]
  • 2. Reading speed and accuracy for 1M [ Time Frame: 6 weeks intervention ] [ Designated as safety issue: No ]
  • 3. Reading performance tests. [ Time Frame: 6 week's intervention ] [ Designated as safety issue: No ]
  • 4. Reading Behavior Inventory [ Time Frame: 6 week's intervention ] [ Designated as safety issue: No ]
  • 5. VFQ-25 plus 2 extra questions). [ Time Frame: 6 week's intervention ] [ Designated as safety issue: No ]
  • 6. Geriatric depression scale [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eccentric viewing
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
Eccentric viewing training for 6 weeks, minimum two 10 minutes per day.
Other Name: eccentric fixation training, vision training
Active Comparator: CCTV arm
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)
A CCTV is an electro-optical device mainly used for reading.
Other Name: EVES, electronic vision enhancement system

Detailed Description:

Age-related macular degeneration is the single most common cause of visual impairment in Canada, affecting people over the age of 55 years. It causes loss of central, detailed vision, resulting in difficulty with fine vision tasks, such as reading and writing. At present there is no fully effective prevention or treatment for this condition, but people do benefit from visual rehabilitation. Two of the most common rehabilitation techniques are eccentric viewing training and an electronic magnification system called a Closed circuit television (CCTV). In eccentric viewing training the person is taught to use his or her remaining side vision, instead of central vision. The CCTV provides high levels of magnification to compensate for the loss of detail vision. The purpose of this randomized clinical trial is to compare the effectiveness of these two interventions. In the study people will be randomly assigned to either receiving eccentric viewing training or a CCTV. This will happen after they have received basic, optical low vision services and training through the CNIB. We will assess their performance with either the CCTV or EV training with a variety of reading tasks and questionnaires. The results will give evidence for how it is most beneficial to use resources and as such will be very important in future planning of low vision services.

Hypothesis: Eccentric Viewing Training will improve reading speed over CCTV by at least 10 words per minute in patients with advanced AMD.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971464

Locations
Canada, Ontario
CNIB, Toronto Branch
Toronto, Ontario, Canada, M4G 3E8
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: William Hodge, MD, PhD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: William Hodge, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00971464     History of Changes
Other Study ID Numbers: R-08-683, 15968E
Study First Received: September 2, 2009
Last Updated: September 7, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
AMD
EV
CCTV
Reading
vision

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014