Clinical trial NCT00971464: Low Vision Study Comparing EV Training vs. CCTV for AMD Rehabilitation
Official title: A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AMD
Keywords: AMD
EV
CCTV
Reading
vision
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: The primary outcome measures reading speed for 1.3M print (in correct words per minute).
timeFrame: 6 weeks intervention
Secondary outcomes:
measure: The secondary outcomes measures 1. Reading accuracy for 1.3M;
timeFrame: 6 weeks intervention
measure: 2. Reading speed and accuracy for 1M
timeFrame: 6 weeks intervention
measure: 3. Reading performance tests.
timeFrame: 6 week's intervention
measure: 4. Reading Behavior Inventory
timeFrame: 6 week's intervention
measure: 5. VFQ-25 plus 2 extra questions).
timeFrame: 6 week's intervention
measure: 6. Geriatric depression scale
timeFrame: 6 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: CNIB, Toronto Branch
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: William Hodge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: