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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

Tracking Information
First Submitted Date  ICMJE March 23, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date January 17, 2019
Actual Study Start Date  ICMJE May 1, 2012
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03109314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining Donepezil With Perceptual Learning in Normal and Amblyopic Human The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
Official Title  ICMJE The Effect of Donepezil on Perceptual Learning in Adult Amblyopia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Amblyopia
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Donepezil
    • Behavioral: Single-letter training
  • 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.
    Interventions:
    • Drug: Donepezil
    • Behavioral: Uncrowd training
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109314
Other Study ID Numbers  ICMJE 020976_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dennis Levi, University of California, Berkeley
Study Sponsor  ICMJE Dennis Levi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis M Levi, OD, PhD University of California, Berkeley
PRS Account University of California, Berkeley
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP