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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00971464
Other study ID # R-08-683
Secondary ID 15968E
Status Completed
Phase Phase 2
First received September 2, 2009
Last updated September 7, 2012
Start date September 2009
Est. completion date September 2011

Study information

Verified date September 2012
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
eccentric viewing (EV) training
Eccentric viewing training for 6 weeks, minimum two 10 minutes per day.
Device:
Closed circuit television (CCTV)
A CCTV is an electro-optical device mainly used for reading.

Locations

Country Name City State
Canada CNIB, Toronto Branch Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measures reading speed for 1.3M print (in correct words per minute). 6 weeks intervention No
Secondary The secondary outcomes measures 1. Reading accuracy for 1.3M; 6 weeks intervention No
Secondary 2. Reading speed and accuracy for 1M 6 weeks intervention No
Secondary 3. Reading performance tests. 6 week's intervention No
Secondary 4. Reading Behavior Inventory 6 week's intervention No
Secondary 5. VFQ-25 plus 2 extra questions). 6 week's intervention No
Secondary 6. Geriatric depression scale 6 week No
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