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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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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

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

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 training

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.

Uncrowd training

Intervention Type BEHAVIORAL

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

Interventions

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Donepezil

Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.

Intervention Type DRUG

Single-letter training

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

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Aricept

Eligibility Criteria

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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

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