Perceptual Learning Treatment for Amblyopia
Primary Purpose
Amblyopia
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acuity training
Occlusion therapy
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia
Eligibility Criteria
Inclusion Criteria:
- Visual acuity in the amblyopic eye: 20/25 or worse
Exclusion Criteria:
- Manifest eye disease & nystagmus
Sites / Locations
- Optometry Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Perceptual learning group - Amblyopia
Perceptual learning group - Control
Occlusion therapy - Amblyopia
Arm Description
Visual training
Visual training
Patching
Outcomes
Primary Outcome Measures
Change of grating acuity
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
Change of visual acuity
Visual acuity tests the participants' ability to resolve letters.This study measures the change of visual acuity after 20 hours of vision training.
Change of contrast sensitivity
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.
Change of stereopsis
Visual acuity tests the 3-D perception. This study measures the change of stereopsis after 20 hours of vision training.
Full Information
NCT ID
NCT03788031
First Posted
December 11, 2018
Last Updated
August 24, 2021
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03788031
Brief Title
Perceptual Learning Treatment for Amblyopia
Official Title
Towards Developing a Perceptual Learning Treatment for Amblyopia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Perceptual learning group - Amblyopia
Arm Type
Experimental
Arm Description
Visual training
Arm Title
Perceptual learning group - Control
Arm Type
Active Comparator
Arm Description
Visual training
Arm Title
Occlusion therapy - Amblyopia
Arm Type
Placebo Comparator
Arm Description
Patching
Intervention Type
Other
Intervention Name(s)
Acuity training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Occlusion therapy
Intervention Description
Participants will be required to patch the good eye for 20 days, 1 hour per day.
Primary Outcome Measure Information:
Title
Change of grating acuity
Description
Grating acuity tests the participants' ability to resolve fine details. This study measures the change of grating acuity after 20 hours of vision training.
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
Change of visual acuity
Description
Visual acuity tests the participants' ability to resolve letters.This study measures the change of visual acuity after 20 hours of vision training.
Time Frame
20 hours
Title
Change of contrast sensitivity
Description
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.
Time Frame
20 hours
Title
Change of stereopsis
Description
Visual acuity tests the 3-D perception. This study measures the change of stereopsis after 20 hours of vision training.
Time Frame
20 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Visual acuity in the amblyopic eye: 20/25 or worse
Exclusion Criteria:
Manifest eye disease & nystagmus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsz Wing Leung, Ph.D.
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Research Clinic
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19008199
Citation
Levi DM, Li RW. Improving the performance of the amblyopic visual system. Philos Trans R Soc Lond B Biol Sci. 2009 Feb 12;364(1515):399-407. doi: 10.1098/rstb.2008.0203.
Results Reference
result
PubMed Identifier
19109504
Citation
Li RW, Klein SA, Levi DM. Prolonged perceptual learning of positional acuity in adult amblyopia: perceptual template retuning dynamics. J Neurosci. 2008 Dec 24;28(52):14223-9. doi: 10.1523/JNEUROSCI.4271-08.2008.
Results Reference
result
PubMed Identifier
21912514
Citation
Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.
Results Reference
result
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Perceptual Learning Treatment for Amblyopia
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