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

AMD Clinical Trial

— AMD  

Official title:

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

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

• AMD

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