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Trial record 6 of 20 for:    "Amblyopia" | "Neurotransmitter Agents"

Combining Donepezil With Perceptual Learning in Normal and Amblyopic Human The Effect of Donepezil on Perceptual Learning in Adult Amblyopia

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ClinicalTrials.gov Identifier: NCT03109314
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Levi, University of California, Berkeley

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Amblyopia Drug: Donepezil Behavioral: Single-letter training Behavioral: Uncrowd training Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: Single-letter training group
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.
Drug: Donepezil
Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.
Other Name: Aricept

Behavioral: Single-letter training
Subjects will undergo training to identify single letters (10,000 trials, or 10 blocks per session for 10 sessions).

Active Comparator: Uncrowd training group
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.
Drug: Donepezil
Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.
Other Name: Aricept

Behavioral: Uncrowd training
Subjects will undergo training to identify letters closely flanked by other letters (10,000 trials, or 10 blocks per session for 10 sessions).




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subjects with amblyopia

Inclusion Criteria:

  • corrected visual acuity being 20/30 or worse in the poorer eye (at least 20/20 in the better eye)
  • reduced stereoacuity
  • normal retina

Exclusion Criteria:

  • with other diagnosed eye diseases

Subjects with normal vision

Inclusion Criteria:

  • corrected visual acuity at least 20/20 in each eye
  • normal stereoacuity
  • normal retina

Exclusion Criteria:

  • with other diagnosed eye diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109314


Locations
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United States, California
University of California, Berkeley
Berkeley, California, United States, 94720
Sponsors and Collaborators
Dennis Levi
Investigators
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Principal Investigator: Dennis M Levi, OD, PhD University of California, Berkeley

Additional Information:
Publications of Results:
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Responsible Party: Dennis Levi, Professor of Optometry and Vision Science, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03109314     History of Changes
Other Study ID Numbers: 020976_01
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dennis Levi, University of California, Berkeley:
amblyopia
donepezil
perceptual learning
crowding
contrast sensitivity
visual acuity
Additional relevant MeSH terms:
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Amblyopia
Neurotransmitter Agents
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Physiological Effects of Drugs
Nootropic Agents