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Perceptual Learning Treatment for Amblyopia

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ClinicalTrials.gov Identifier: NCT03788031
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief Summary:

Objectives. To develop a new treatment for amblyopia using a perceptual learning approach.

Hypothesis to be tested. Our proposed experiments are designed to investigate whether practicing a grating detection task can improve vision in patients with amblyopia.

Design and subjects. A total of 36 patients with amblyopia will be randomized allocated into two intervention groups: Group 1, perceptual learning therapy. Group 2, occlusion therapy. A control group comprising of 18 subjects with normal vision will be recruited for comparison. A battery of tests will be used to assess a range of visual functions before and after the treatment intervention.

Study instruments. Grating acuity testing system

Interventions. We have established a clinical protocol for acuity training. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to indicate the location of the stimulus. Participants will be required to undertake 20 one-hour sessions of training.

Main outcome measures. Resolution acuity, visual acuity, contrast sensitivity function


Condition or disease Intervention/treatment Phase
Amblyopia Other: Acuity training Other: Occlusion therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Towards Developing a Perceptual Learning Treatment for Amblyopia
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: Perceptual learning group - Amblyopia
Visual training
Other: Acuity training
The intervention will be a vision therapy. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to identify the location of the stimulus.

Active Comparator: Perceptual learning group - Control
Visual training
Other: Acuity training
The intervention will be a vision therapy. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to identify the location of the stimulus.

Placebo Comparator: Occlusion therapy - Amblyopia
Patching
Other: Occlusion therapy
Participants will be required to patch the good eye for 20 days, 1 hour per day.




Primary Outcome Measures :
  1. Change of grating acuity [ Time Frame: 20 hours ]
    Grating acuity tests the participants' ability to resolve fine details. This study measures the change of grating acuity after 20 hours of vision training.


Secondary Outcome Measures :
  1. Change of visual acuity [ Time Frame: 20 hours ]
    Visual acuity tests the participants' ability to resolve letters.This study measures the change of visual acuity after 20 hours of vision training.

  2. Change of contrast sensitivity [ Time Frame: 20 hours ]
    Contrast sensitivity reflects the participants' sensitivity to identify low contrast visual stimuli. This study measures the change of contrast sensitivity after 20 hours of vision training.

  3. Change of stereopsis [ Time Frame: 20 hours ]
    Visual acuity tests the 3-D perception. This study measures the change of stereopsis after 20 hours of vision training.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Visual acuity in the amblyopic eye: 20/25 or worse

Exclusion Criteria:

  • Manifest eye disease & nystagmus

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): NCT03788031


Contacts
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Contact: Tsz Wing Leung, Ph.D. 27664268 jeffrey.TW.leung@polyu.edu.hk

Locations
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Hong Kong
Optometry Research Clinic Recruiting
Hong Kong, Hong Kong
Contact: Chea-su Kee, Ph.D.       c.kee@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Tsz Wing Leung, Ph.D. The Hong Kong Polytechnic University

Publications of Results:
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03788031    
Other Study ID Numbers: HSEARS20171108002
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms