AMDPhase 2AMDNCT00971464
Low Vision Study Comparing EV Training vs. CCTV for AMD Rehabilitation
A Phase 2 study testing eccentric viewing (EV) training and Closed circuit television (CCTV) in people with AMD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD
- What is being tested?
- eccentric viewing (EV) training and Closed circuit television (CCTV)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration
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.
Read the 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.
- Conditions
- AMD
- Being tested
- eccentric viewing (EV) training, Closed circuit television (CCTV)
- Keywords
- AMD, EV, CCTV, Reading, vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eccentric viewing (EV) trainingBehavioural
Also called eccentric fixation training, vision training
Eccentric viewing training for 6 weeks, minimum two 10 minutes per day.
Closed circuit television (CCTV)Device
Also called EVES, electronic vision enhancement system
A CCTV is an electro-optical device mainly used for reading.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric viewing | Experimental | 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. Receives: Behavioral: eccentric viewing (EV) training |
| CCTV arm | Active comparator | 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. Receives: Device: Closed circuit television (CCTV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures reading speed for 1.3M print (in correct words per minute).
Measured: 6 weeks intervention
Secondary outcomes (6)
The secondary outcomes measures 1. Reading accuracy for 1.3M;
Measured: 6 weeks intervention
2. Reading speed and accuracy for 1M
Measured: 6 weeks intervention
3. Reading performance tests.
Measured: 6 week's intervention
4. Reading Behavior Inventory
Measured: 6 week's intervention
5. VFQ-25 plus 2 extra questions).
Measured: 6 week's intervention
6. Geriatric depression scale
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hodge, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- William Hodge, MD, PhD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971464
- Sponsor's protocol ID
- R-08-683
- Other IDs
- 15968E
- Acronym
- AMD
- Status last verified
- Sep 2012
- First submitted
- 2 Sep 2009
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00971464
- Acronym / sponsor ID
- AMD / R-08-683
- Conditions
- AMD
- Keywords
- AMD, EV, CCTV, Reading, vision
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric viewing | Experimental | Behavioral: eccentric viewing (EV) trainingEccentric 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. |
| CCTV arm | Active comparator | Device: Closed circuit television (CCTV)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eccentric viewing (EV) trainingAlso: eccentric fixation training, vision trainingEccentric viewing training for 6 weeks, minimum two 10 minutes per day. | Behavioural | Eccentric viewing |
| Closed circuit television (CCTV)Also: EVES, electronic vision enhancement systemA CCTV is an electro-optical device mainly used for reading. | Device | CCTV arm |
Primary outcome
The primary outcome measures reading speed for 1.3M print (in correct words per minute).
Time frame: 6 weeks intervention
6 secondary outcomes
The secondary outcomes measures 1. Reading accuracy for 1.3M;
Time frame: 6 weeks intervention
2. Reading speed and accuracy for 1M
Time frame: 6 weeks intervention
3. Reading performance tests.
Time frame: 6 week's intervention
4. Reading Behavior Inventory
Time frame: 6 week's intervention
5. VFQ-25 plus 2 extra questions).
Time frame: 6 week's intervention
6. Geriatric depression scale
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
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Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Hodge, MD, PhD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eccentric viewing (EV) training and Closed circuit television (CCTV) in people with AMD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures reading speed for 1.3M print (in correct words per minute). (time frame: 6 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.