Age Related MaculopathyNCT00125632
Measuring Reading Rehabilitation Outcomes
A study testing Eccentric Viewing Training for Reading in people with Age Related Maculopathy and Retinal Degeneration, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Maculopathy, Retinal Degeneration
- What is being tested?
- Eccentric Viewing Training for Reading
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of AMD
- An established preferred retinal locus
- Visual acuity of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)
Who cannot join
- Those with other major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
About this study
The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with age-related macular degeneration.
Read the detailed description
Age-related macular degeneration (AMD) is currently among the top three leading causes of central vision loss in veterans (Chomsky et al., 1995) and is the most prevalent cause of blindness among veterans (37.2%, Quillen \& Henry, 2000). The loss of central vision associated with these diseases has a profound impact on the quality of life of those affected, with many suffering depression. It is devastating to no longer be able to read a newspaper or recognize facial expressions. The use of preferred retinal locations (PRLs) to compensate for diseased foveae has offered hope to these patients in regaining some function. The investigators have developed a protocol that includes training in three major visual skills areas:
- visual awareness and eccentric viewing;
- reading eye movements; and
- processing of sequentially presented lexical information.
Module 1 focuses on making the patient aware of better vision at an eccentric location relative to degraded vision at the diseased fovea. Module 2 is focused on the improvement of the control of eye movements with the PRL. Module 3 is focused on reading practice without eye movements. These program curriculums and preliminary results are provided in the present proposal. The primary aim of this proposal is to quantitatively assess the relative effectiveness for improving reading and to establish the minimum training time need for skill improvement. Sixty patients with AMD who are already using a PRL will be selected to be similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of disease) and included in an experimental group. All patients in the experimental group will be trained with all three modules using a repeated measures - completely counterbalanced - design to control for training order effects. An additional 24 AMD patients will be recruited for a control group to be tested at the same time intervals as the experimental patients, but do not receive training between these assessment period intervals. The control group patients will be given the option to receive training following the assessment period. Both the experimental and the control patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts, the Pepper Visual Skills for Reading (VSR) Test, and the View Sentences Test). The performance of the experimental patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Any change in performance of the experimental patients will be compared to the test-retest performance of the control patients. A questionnaire (the Veterans Administration Low Vision Visual Functioning Questionnaire) will also be administered to assess perceived abilities to perform everyday tasks before and following training. The control patients will also receive the questionnaire before and after their assessment period. In addition, the experimental patients will also be assessed on the exercises practiced during the module at the end of each daily training session to determine exactly when in the training protocol an improvement in performance on the exercises being trained has occurred. These daily performance measures provide for a finer scale for detecting performance changes. Statistical analyses will be conducted to answer the following key questions:
- What visual skills related to reading are trainable?
- Which methods are best for training these skills?
- What is the time course of visual skill improvement?
- Do the answers to these questions depend upon individual patient characteristics (e.g., age, disease severity, PRL location, cognitive factors)?
- Do patients who do not undergo training, but have repeated reading performance assessments, show improvements in reading skills?
Advances are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of standard clinical care, it is likely that the patients will require vision rehabilitation techniques to help them make sense of their potentially fragmented percepts. This research offers an evaluation of relative successes of the components of reading rehabilitation and will lead to the design of an efficient and effective composite training strategy.
- Conditions
- Age Related Maculopathy, Retinal Degeneration
- Being tested
- Eccentric Viewing Training for Reading
- Keywords
- Reading, Rehabilitation, Treatment Outcomes, Low vision
- Medical subject headings
- Macular Degeneration, Retinal Degeneration, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric Viewing Training for ReadingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startAug 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age Related MaculopathyStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Janet P Szlyk, Ph.D., Principal investigator, Research & Development Service 151, Jesse Brown VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125632
- Sponsor's protocol ID
- O3877R
- Status last verified
- Dec 2006
- First submitted
- 28 Jul 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
Publications
Szlyk JP, Paliga J, Seiple W, Rabb MF. Comprehensive functional vision assessment of patients with North Carolina macular dystrophy (MCDR1). Retina. 2005 Jun;25(4):489-97. doi: 10.1097/00006982-200506000-00015.
PubMed 15933597Grant P, Seiple W, Szlyk JP. Effect of depression on actual and perceived effects of reading rehabilitation for people with central vision loss. J Rehabil Res Dev. 2011;48(9):1101-8. doi: 10.1682/jrrd.2010.05.0080.
PubMed 22234714Seiple W, Grant P, Szlyk JP. Reading rehabilitation of individuals with AMD: relative effectiveness of training approaches. Invest Ophthalmol Vis Sci. 2011 May 5;52(6):2938-44. doi: 10.1167/iovs.10-6137.
PubMed 21296824
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Reading Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT00125632
- Acronym / sponsor ID
- O3877R
- Conditions
- Age Related Maculopathy, Retinal Degeneration
- Keywords
- Reading, Rehabilitation, Treatment Outcomes, Low vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Study completion
- May 2008 (actual)
- First posted
- 1 Aug 2005 (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.
The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with age-related macular degeneration.
Detailed description
Age-related macular degeneration (AMD) is currently among the top three leading causes of central vision loss in veterans (Chomsky et al., 1995) and is the most prevalent cause of blindness among veterans (37.2%, Quillen \& Henry, 2000). The loss of central vision associated with these diseases has a profound impact on the quality of life of those affected, with many suffering depression. It is devastating to no longer be able to read a newspaper or recognize facial expressions. The use of preferred retinal locations (PRLs) to compensate for diseased foveae has offered hope to these patients in regaining some function. The investigators have developed a protocol that includes training in three major visual skills areas:
- visual awareness and eccentric viewing;
- reading eye movements; and
- processing of sequentially presented lexical information.
Module 1 focuses on making the patient aware of better vision at an eccentric location relative to degraded vision at the diseased fovea. Module 2 is focused on the improvement of the control of eye movements with the PRL. Module 3 is focused on reading practice without eye movements. These program curriculums and preliminary results are provided in the present proposal. The primary aim of this proposal is to quantitatively assess the relative effectiveness for improving reading and to establish the minimum training time need for skill improvement. Sixty patients with AMD who are already using a PRL will be selected to be similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of disease) and included in an experimental group. All patients in the experimental group will be trained with all three modules using a repeated measures - completely counterbalanced - design to control for training order effects. An additional 24 AMD patients will be recruited for a control group to be tested at the same time intervals as the experimental patients, but do not receive training between these assessment period intervals. The control group patients will be given the option to receive training following the assessment period. Both the experimental and the control patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts, the Pepper Visual Skills for Reading (VSR) Test, and the View Sentences Test). The performance of the experimental patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Any change in performance of the experimental patients will be compared to the test-retest performance of the control patients. A questionnaire (the Veterans Administration Low Vision Visual Functioning Questionnaire) will also be administered to assess perceived abilities to perform everyday tasks before and following training. The control patients will also receive the questionnaire before and after their assessment period. In addition, the experimental patients will also be assessed on the exercises practiced during the module at the end of each daily training session to determine exactly when in the training protocol an improvement in performance on the exercises being trained has occurred. These daily performance measures provide for a finer scale for detecting performance changes. Statistical analyses will be conducted to answer the following key questions:
- What visual skills related to reading are trainable?
- Which methods are best for training these skills?
- What is the time course of visual skill improvement?
- Do the answers to these questions depend upon individual patient characteristics (e.g., age, disease severity, PRL location, cognitive factors)?
- Do patients who do not undergo training, but have repeated reading performance assessments, show improvements in reading skills?
Advances are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of standard clinical care, it is likely that the patients will require vision rehabilitation techniques to help them make sense of their potentially fragmented percepts. This research offers an evaluation of relative successes of the components of reading rehabilitation and will lead to the design of an efficient and effective composite training strategy.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of AMD
- An established preferred retinal locus
- Visual acuity of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)
Key exclusion criteria (1 listed)
- Those with other major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment
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 Training for Reading | Procedure or surgery | – |
Primary outcome
Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.
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 5 Feb 2009.
- Background: PubMed 15933597Szlyk JP, Paliga J, Seiple W, Rabb MF. Comprehensive functional vision assessment of patients with North Carolina macular dystrophy (MCDR1). Retina. 2005 Jun;25(4):489-97. doi: 10.1097/00006982-200506000-00015.
- Derived from this study: PubMed 22234714Grant P, Seiple W, Szlyk JP. Effect of depression on actual and perceived effects of reading rehabilitation for people with central vision loss. J Rehabil Res Dev. 2011;48(9):1101-8. doi: 10.1682/jrrd.2010.05.0080.
- Derived from this study: PubMed 21296824Seiple W, Grant P, Szlyk JP. Reading rehabilitation of individuals with AMD: relative effectiveness of training approaches. Invest Ophthalmol Vis Sci. 2011 May 5;52(6):2938-44. doi: 10.1167/iovs.10-6137.
- Related InfoLink provided by the sponsor.
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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.
Janet P Szlyk, Ph.D. principal investigator
Research & Development Service 151, Jesse Brown VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Viewing Training for Reading in people with Age Related Maculopathy and Retinal Degeneration, run by US Department of Veterans Affairs at 1 site in United States.
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 3 inclusion and 1 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 5 Feb 2009. 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 United States. 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.
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?
Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125632, which also lists 3 linked publications.
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 5 Feb 2009.