AmblyopiaPhase 4NCT03109314
Combining Donepezil With Perceptual Learning in Normal and Amblyopic Human The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
A Phase 4 study testing Donepezil, Single-letter training and Uncrowd training in people with Amblyopia, run by Dennis Levi at 1 site in United States.
Trial summary
The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Donepezil, Single-letter training and Uncrowd training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2012to 1 Dec 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- corrected visual acuity being 20/30 or worse in the poorer eye (at least 20/20 in the better eye)
- reduced stereoacuity
- normal retina
- corrected visual acuity at least 20/20 in each eye
- normal stereoacuity
- normal retina
Who cannot join
- with other diagnosed eye diseases
- Subjects with normal vision
- with other diagnosed eye diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.
Read the detailed description
The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.
In this study, donepezil will be administered while amblyopic subjects (or normally sighted subjects tested in the periphery) are trained on a low-contrast single-letter recognition task, or an uncrowd task (recognizing a letter closely embedded within two other letters). Subjects will be asked to identify the target letter (the low-contrast single letter, or the letter embedded within other letters). Training will take place for 10 consecutive days. Pre- and post-tests will be conducted immediately before and after training, and will consist of the measurements of visual acuity, crowding extent and contrast threshold for recognizing single letters.
- Conditions
- Amblyopia
- Being tested
- Donepezil, Single-letter training, Uncrowd training
- Keywords
- amblyopia, donepezil, perceptual learning, crowding, contrast sensitivity, visual acuity
- Medical subject headings
- Amblyopia, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept
Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.
Single-letter trainingBehavioural
Subjects will undergo training to identify single letters (10,000 trials, or 10 blocks per session for 10 sessions).
Uncrowd trainingBehavioural
Subjects will undergo training to identify letters closely flanked by other letters (10,000 trials, or 10 blocks per session for 10 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Single-letter training group | Active comparator | Subjects will be trained on a low-contrast single-letter task. The task is to identify a faint letter (low-contrast). Performance will be measured as correct or incorrect. Training will consist of identifying these low-contrast letters for 1000 trials per day (10 blocks of 100 trials each, subjects can take breaks in-between blocks), for a total of 10 days. During training, subjects will be administered a daily dosage of 5 mg of donepezil. Immediately before and after training (the day before and the day after), subjects' performance on (1) visual acuity; (2) contrast for identifying letters and (3) crowding extent will be measured. Receives: Drug: Donepezil; Behavioral: Single-letter training |
| Uncrowd training group | Active comparator | Subjects will be trained on an uncrowd task (identifying the middle letter of groups of three letters presented). Performance will be measured as correct or incorrect. Training will consist of identifying these letters for 1000 trials per day (10 blocks of 100 trials each, subjects can take breaks in-between blocks), for a total of 10 days. During training, subjects will be administered a daily dosage of 5 mg of donepezil. Immediately before and after training (the day before and the day after), subjects' performance on (1) visual acuity; (2) contrast for identifying letters and (3) crowding extent will be measured. Receives: Drug: Donepezil; Behavioral: Uncrowd training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in percent-correct performance in the respective training task
During training, for each trial, participants' responses can be categorized as correct or incorrect. The investigators will use the percent-correct performance to quantify the performance in each block, and this percent-correct performance will be measured throughout training (i.e. for each block on each day (10 blocks per day), and for 10 training days).
Measured: During training (performance will be summarized for each block of trials (a block takes approximately 5 - 10 min to complete). In other words, there should be 100 points of measurements throughout the training period.)
Visual acuity (the smallest letter the participants can see)
The change in visual acuity before and after (one day before and one day after) training will be compared. The change will be expressed as a ratio.
Measured: Immediately (one day) before and after training
Contrast sensitivity for identifying single letters (the lowest contrast required to identify letters)
Contrast refers to the smallest difference in luminance between a letter and its background. This is a standard clinical measurement. Essentially, the lowest contrast letter is also the faintest letter that a participant can see. The change in contrast sensitivity for identifying single letters before and after (one day before and one day after) training will be compared. The change will be expressed as a ratio.
Measured: Immediately (one day) before and after training
Crowding extent (the extent over which adjacent letters will affect the recognition of a letter)
Crowding extent refers to the minimum distance between adjacent letters such that the presence of adjacent letters affects the recognition of a target letter. Usually the letter separation will be adjusted until the adjacent letters no longer affects how well the middle letter can be recognized. This distance is the crowding extent. The change in the crowding extent before and after (one day before and one day after) training will be measured. The change will be expressed as a ratio.
Measured: Immediately (one day) before and after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2012
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Levi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dennis Levi, University of California, Berkeley
- Investigators
- Dennis M Levi, OD, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109314
- Sponsor's protocol ID
- 020976_01
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung STL, Li RW, Silver MA, Levi DM. Donepezil Does Not Enhance Perceptual Learning in Adults with Amblyopia: A Pilot Study. Front Neurosci. 2017 Aug 7;11:448. doi: 10.3389/fnins.2017.00448. eCollection 2017.
PubMed 28824369
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
- ClinicalTrials.gov ID
- NCT03109314
- Acronym / sponsor ID
- 020976_01
- Conditions
- Amblyopia
- Keywords
- amblyopia, donepezil, perceptual learning, crowding, contrast sensitivity, visual acuity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dennis LeviUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.
Detailed description
The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.
In this study, donepezil will be administered while amblyopic subjects (or normally sighted subjects tested in the periphery) are trained on a low-contrast single-letter recognition task, or an uncrowd task (recognizing a letter closely embedded within two other letters). Subjects will be asked to identify the target letter (the low-contrast single letter, or the letter embedded within other letters). Training will take place for 10 consecutive days. Pre- and post-tests will be conducted immediately before and after training, and will consist of the measurements of visual acuity, crowding extent and contrast threshold for recognizing single letters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-letter training group | Active comparator | Drug: Donepezil, Behavioral: Single-letter trainingSubjects will be trained on a low-contrast single-letter task. The task is to identify a faint letter (low-contrast). Performance will be measured as correct or incorrect. Training will consist of identifying these low-contrast letters for 1000 trials per day (10 blocks of 100 trials each, subjects can take breaks in-between blocks), for a total of 10 days. During training, subjects will be administered a daily dosage of 5 mg of donepezil. Immediately before and after training (the day before and the day after), subjects' performance on (1) visual acuity; (2) contrast for identifying letters and (3) crowding extent will be measured. |
| Uncrowd training group | Active comparator | Drug: Donepezil, Behavioral: Uncrowd trainingSubjects will be trained on an uncrowd task (identifying the middle letter of groups of three letters presented). Performance will be measured as correct or incorrect. Training will consist of identifying these letters for 1000 trials per day (10 blocks of 100 trials each, subjects can take breaks in-between blocks), for a total of 10 days. During training, subjects will be administered a daily dosage of 5 mg of donepezil. Immediately before and after training (the day before and the day after), subjects' performance on (1) visual acuity; (2) contrast for identifying letters and (3) crowding extent will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- corrected visual acuity being 20/30 or worse in the poorer eye (at least 20/20 in the better eye)
- reduced stereoacuity
- normal retina
- corrected visual acuity at least 20/20 in each eye
- normal stereoacuity
Key exclusion criteria (3 listed)
- with other diagnosed eye diseases
- Subjects with normal vision
- with other diagnosed eye diseases
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 |
|---|---|---|
| DonepezilAlso: AriceptDonepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training. | Drug | Single-letter training group, Uncrowd training group |
| Single-letter trainingSubjects will undergo training to identify single letters (10,000 trials, or 10 blocks per session for 10 sessions). | Behavioural | Single-letter training group |
| Uncrowd trainingSubjects will undergo training to identify letters closely flanked by other letters (10,000 trials, or 10 blocks per session for 10 sessions). | Behavioural | Uncrowd training group |
Primary outcome
Improvement in percent-correct performance in the respective training task
Time frame: During training (performance will be summarized for each block of trials (a block takes approximately 5 - 10 min to complete). In other words, there should be 100 points of measurements throughout the training period.)
During training, for each trial, participants' responses can be categorized as correct or incorrect. The investigators will use the percent-correct performance to quantify the performance in each block, and this percent-correct performance will be measured throughout training (i.e. for each block on each day (10 blocks per day), and for 10 training days).
Visual acuity (the smallest letter the participants can see)
Time frame: Immediately (one day) before and after training
The change in visual acuity before and after (one day before and one day after) training will be compared. The change will be expressed as a ratio.
Contrast sensitivity for identifying single letters (the lowest contrast required to identify letters)
Time frame: Immediately (one day) before and after training
Contrast refers to the smallest difference in luminance between a letter and its background. This is a standard clinical measurement. Essentially, the lowest contrast letter is also the faintest letter that a participant can see. The change in contrast sensitivity for identifying single letters before and after (one day before and one day after) training will be compared. The change will be expressed as a ratio.
Crowding extent (the extent over which adjacent letters will affect the recognition of a letter)
Time frame: Immediately (one day) before and after training
Crowding extent refers to the minimum distance between adjacent letters such that the presence of adjacent letters affects the recognition of a target letter. Usually the letter separation will be adjusted until the adjacent letters no longer affects how well the middle letter can be recognized. This distance is the crowding extent. The change in the crowding extent before and after (one day before and one day after) training will be measured. The change will be expressed as a ratio.
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 17 Jan 2019.
- Results publication: PubMed 28824369Chung STL, Li RW, Silver MA, Levi DM. Donepezil Does Not Enhance Perceptual Learning in Adults with Amblyopia: A Pilot Study. Front Neurosci. 2017 Aug 7;11:448. doi: 10.3389/fnins.2017.00448. eCollection 2017.
- Article in Frontiers in NeuroscienceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dennis M Levi, OD, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil, Single-letter training and Uncrowd training in people with Amblyopia, run by Dennis Levi 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 6 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 17 Jan 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement in percent-correct performance in the respective training task (time frame: During training (performance will be summarized for each block of trials (a block takes approximately 5 - 10 min to complete). In other words, there should be 100 points of measurements throughout the training period.)). The study lists 4 primary outcomes in all. 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 NCT03109314, which also lists 1 linked publication.
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 17 Jan 2019.