AmblyopiaNCT03788031
Perceptual Learning Treatment for Amblyopia
A study testing Acuity training and Occlusion therapy in people with Amblyopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Acuity training and Occlusion therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Visual acuity in the amblyopic eye: 20/25 or worse
Who cannot join
- Manifest eye disease \& nystagmus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Developing a Perceptual Learning Treatment for Amblyopia
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.
Read more
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
- Conditions
- Amblyopia
- Being tested
- Acuity training, Occlusion therapy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuity trainingOther
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.
Occlusion therapyOther
Participants will be required to patch the good eye for 20 days, 1 hour per day.
| Study group | Role | What they receive |
|---|---|---|
| Perceptual learning group - Amblyopia | Experimental | Visual training Receives: Other: Acuity training |
| Perceptual learning group - Control | Active comparator | Visual training Receives: Other: Acuity training |
| Occlusion therapy - Amblyopia | Placebo comparator | Patching Receives: Other: Occlusion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 hours
Secondary outcomes (3)
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.
Measured: 20 hours
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.
Measured: 20 hours
Change of stereopsis
Visual acuity tests the 3-D perception. This study measures the change of stereopsis after 20 hours of vision training.
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start1 Mar 2019
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsz Wing Leung, Ph.D., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788031
- Sponsor's protocol ID
- HSEARS20171108002
- Status last verified
- Aug 2021
- First submitted
- 11 Dec 2018
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19008199Li 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.
PubMed 19109504Li 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.
PubMed 21912514
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Developing a Perceptual Learning Treatment for Amblyopia
- ClinicalTrials.gov ID
- NCT03788031
- Acronym / sponsor ID
- HSEARS20171108002
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perceptual learning group - Amblyopia | Experimental | Other: Acuity trainingVisual training |
| Perceptual learning group - Control | Active comparator | Other: Acuity trainingVisual training |
| Occlusion therapy - Amblyopia | Placebo comparator | Other: Occlusion therapyPatching |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Visual acuity in the amblyopic eye: 20/25 or worse
Key exclusion criteria (1 listed)
- Manifest eye disease \& nystagmus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuity trainingThe 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. | Other | Perceptual learning group - Amblyopia, Perceptual learning group - Control |
| Occlusion therapyParticipants will be required to patch the good eye for 20 days, 1 hour per day. | Other | Occlusion therapy - Amblyopia |
Primary outcome
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.
3 secondary outcomes
Change of visual acuity
Time frame: 20 hours
Change of contrast sensitivity
Time frame: 20 hours
Change of stereopsis
Time frame: 20 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Results publication: PubMed 19008199Levi 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 publication: PubMed 19109504Li 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 publication: PubMed 21912514Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsz Wing Leung, Ph.D. principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuity training and Occlusion therapy in people with Amblyopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of grating acuity (time frame: 20 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788031, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.