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Completed

NCT Number: NCT00971464

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

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.

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Key information

Conditions

AMD

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CNIB, Toronto Branch

Toronto, Ontario, M4G 3E8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

eccentric viewing (EV) training

Behavioral

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

Other names: eccentric fixation training, vision training

Closed circuit television (CCTV)

Device

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

Other names: EVES, electronic vision enhancement system

Primary outcomes

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

    Time frame: 6 weeks intervention

Secondary outcomes

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

    Time frame: 6 weeks intervention

  2. 2. Reading speed and accuracy for 1M

    Time frame: 6 weeks intervention

  3. 3. Reading performance tests.

    Time frame: 6 week's intervention

  4. 4. Reading Behavior Inventory

    Time frame: 6 week's intervention

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

    Time frame: 6 week's intervention

  6. 6. Geriatric depression scale

    Time frame: 6 week

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration

Acronym: AMD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2009
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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