Age Related MaculopathyNCT00746668
A Multi-Center Study of Reading Rehabilitation in Macular Disease
A study testing Module 1: Visual Awareness and Eccentric Viewing and Module 3: Reading Practice with RSVP 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 macular disease, including 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?
- Module 1: Visual Awareness and Eccentric Viewing and Module 3: Reading Practice with RSVP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 macular disease, such as age-related macular degeneration
- 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 VAMC (WestSide Division)
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 macular disease, including 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 to 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 two major visual skills areas:
- Visual awareness and eccentric viewing; and
- Reading practice with sequentially 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 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. One hundred and twenty patients with macular disease who are already using a PRL and similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of the disease) will be included the study. All patients will be trained with both modules using a repeated measures-completely counterbalanced - design to control for training order effects. In addition, all patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts and the View Sentences Test). The performance of the patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Questionnaires (the Veterans Administration Low Vision Visual Functioning Questionnaire, CES-D, Short Form-36, and Adaptation to Vision Loss Scale) will also be administered to assess perceived abilities to perform everyday tasks, adaptation to vision loss, moods, and general health. In addition, 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 questions:
- Does a combination of eccentric viewing awareness and oculomotor training produce significant improvements in reading rate?
- Which exercises are most effective in training the visual skills associated with reading and at what point during the course of training do the patients reach asymptotic performance?
- How do co-factors such as age, PRL size and location, and cognitive capabilities relate to training outcomes?
Advancements are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of the standard clinical care, it is likely that all 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
- Module 1: Visual Awareness and Eccentric Viewing, Module 2: Control of Reading Eye Movements, Module 3: Reading Practice with RSVP
- Keywords
- Reading, Macular Degeneration, Rehabilitation, Vision, Low
- 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.
Module 1: Visual Awareness and Eccentric ViewingBehavioural
In this module, awareness of the PRL location and eccentric viewing were trained. Exercises based on published sources were administered. One example of these exercises is the clock face display adapted from Holcomb and Goodrich and Maplesden.
This module also focused on awareness of the perceptual consequences of using a PRL. The purpose of these training exercises was to allow the subjects to appreciate perceptual alterations that occur when using a PRL and to practice making perceptual discriminations with the peripheral retina. Previously published work has demonstrated that perception in the peripheral retina can be affected by practice.
Module 2: Control of Reading Eye MovementsBehavioural
In this module, control of eye movements was trained. These exercises began with a series of saccade tasks to nonalphabetical stimuli and then progressed to single letter, letter pairs, and word stimuli. Subjects were instructed to make a saccade between the dots. The experimenter provided feedback concerning the appropriateness of the saccades, and the alternation rate of the dots was increased as performance improved.
Module 3: Reading Practice with RSVPBehavioural
Also called Sequential Presentation of Lexical Information
In module 3, we wanted to assess only the higher-level effects of reading practice. Subjects practiced reading using stimuli that did not require reading eye movements. An example is short sentences that were presented one word at a time at a single location on a screen (Rapid Serial Visual Presentation [RSVP]). At the end of the sentence, subjects reported whether the sentence made sense or not. We also had our subjects practice reading scrolled text. Although, eye movements and saccades may spontaneously occur under the text presentation conditions of this module, they are not the efficient saccades necessary for reading.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed. Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 1 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 2 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 3 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 4 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 5 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
| Group 6 | Experimental | The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing) Receives: Behavioral: Module 1: Visual Awareness and Eccentric Viewing; Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentence Reading
To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).
Measured: Pre-training, 6 weeks, 12 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Janet P Szlyk, PhD, Principal investigator, Jesse Brown VAMC (WestSide Division)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746668
- Sponsor's protocol ID
- C6246-R
- Status last verified
- Feb 2015
- First submitted
- 3 Sep 2008
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study of Reading Rehabilitation in Macular Disease
- ClinicalTrials.gov ID
- NCT00746668
- Acronym / sponsor ID
- C6246-R
- Conditions
- Age Related Maculopathy, Retinal Degeneration
- Keywords
- Reading, Macular Degeneration, Rehabilitation, Vision, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Posted 27 Feb 2015
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 macular disease, including 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 to 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 two major visual skills areas:
- Visual awareness and eccentric viewing; and
- Reading practice with sequentially 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 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. One hundred and twenty patients with macular disease who are already using a PRL and similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of the disease) will be included the study. All patients will be trained with both modules using a repeated measures-completely counterbalanced - design to control for training order effects. In addition, all patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts and the View Sentences Test). The performance of the patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Questionnaires (the Veterans Administration Low Vision Visual Functioning Questionnaire, CES-D, Short Form-36, and Adaptation to Vision Loss Scale) will also be administered to assess perceived abilities to perform everyday tasks, adaptation to vision loss, moods, and general health. In addition, 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 questions:
- Does a combination of eccentric viewing awareness and oculomotor training produce significant improvements in reading rate?
- Which exercises are most effective in training the visual skills associated with reading and at what point during the course of training do the patients reach asymptotic performance?
- How do co-factors such as age, PRL size and location, and cognitive capabilities relate to training outcomes?
Advancements are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of the standard clinical care, it is likely that all 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPSubjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed. |
| Group 1 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP) |
| Group 2 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing) |
| Group 3 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements) |
| Group 4 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements) |
| Group 5 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP) |
| Group 6 | Experimental | Behavioral: Module 1: Visual Awareness and Eccentric Viewing, Behavioral: Module 2: Control of Reading Eye Movements, Behavioral: Module 3: Reading Practice with RSVPThe subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing) |
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 macular disease, such as age-related macular degeneration
- 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 (3 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 |
|---|---|---|
| Module 1: Visual Awareness and Eccentric ViewingIn this module, awareness of the PRL location and eccentric viewing were trained. Exercises based on published sources were administered. One example of these exercises is the clock face display adapted from Holcomb and Goodrich and Maplesden. This module also focused on awareness of the perceptual consequences of using a PRL. The purpose of these training exercises was to allow the subjects to appreciate perceptual alterations that occur when using a PRL and to practice making perceptual discriminations with the peripheral retina. Previously published work has demonstrated that perception in the peripheral retina can be affected by practice. | Behavioural | Control Group, Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Module 2: Control of Reading Eye MovementsIn this module, control of eye movements was trained. These exercises began with a series of saccade tasks to nonalphabetical stimuli and then progressed to single letter, letter pairs, and word stimuli. Subjects were instructed to make a saccade between the dots. The experimenter provided feedback concerning the appropriateness of the saccades, and the alternation rate of the dots was increased as performance improved. | Behavioural | Control Group, Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Module 3: Reading Practice with RSVPAlso: Sequential Presentation of Lexical InformationIn module 3, we wanted to assess only the higher-level effects of reading practice. Subjects practiced reading using stimuli that did not require reading eye movements. An example is short sentences that were presented one word at a time at a single location on a screen (Rapid Serial Visual Presentation [RSVP]). At the end of the sentence, subjects reported whether the sentence made sense or not. We also had our subjects practice reading scrolled text. Although, eye movements and saccades may spontaneously occur under the text presentation conditions of this module, they are not the efficient saccades necessary for reading. | Behavioural | Control Group, Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Sentence Reading
Time frame: Pre-training, 6 weeks, 12 weeks, 18 weeks
To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, PhD principal investigator
Jesse Brown VAMC (WestSide Division)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Module 1: Visual Awareness and Eccentric Viewing and Module 3: Reading Practice with RSVP 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 3 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 27 Feb 2015. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sentence Reading (time frame: Pre-training, 6 weeks, 12 weeks, 18 weeks). 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 27 Feb 2015.