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

NCT03109314 | Completed Phase 4 FDA Drug

• 1 other identifier: 020976_01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Keywords

amblyopia; donepezil; perceptual learning; crowding; contrast sensitivity; visual acuity

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Immediately (one day) before and after training

Study Arms (2)

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.

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.

Drug: Donepezil; Behavioral: Uncrowd training

Interventions

Donepezil DRUG

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

Also known as: Aricept

Single-letter training group; Uncrowd training group

Single-letter training BEHAVIORAL

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

Single-letter training group

Uncrowd training BEHAVIORAL

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

Uncrowd training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• with other diagnosed eye diseases
• Subjects with normal vision
• corrected visual acuity at least 20/20 in each eye
• normal stereoacuity
• normal retina
• with other diagnosed eye diseases

Sponsors & Collaborators

• Dennis Levi: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (1)

• 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.

  PMID: 28824369 RESULT

Related Links

• Article in Frontiers in Neuroscience

MeSH Terms

Conditions

Amblyopia; Crowding

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Dennis M Levi, OD, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Optometry and Vision Science

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)