AmblyopiaNCT07764198
A Randomized Controlled Trial of Gabor-Based Perceptual Learning for Adult Amblyopia
A study testing Gabor training in people with Amblyopia and Anisometropia, run by Jiannan Huang at 1 site in China.
Trial summary
This study is initiated and conducted by the Shanghai Eye Disease Prevention and Treatment Center / Shanghai Eye Hospital. Many people once believed that amblyopia (commonly known as "lazy eye") could only be treated during childhood (the critical period of visual development) and that nothing could be done once we… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Amblyopia, Anisometropia
- What is being tested?
- Gabor training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent; age 18-39 years inclusive at randomization.
- Diagnosis of amblyopia, with amblyopic-eye BCVA of approximately 20-70 ETDRS letters (approximately decimal BCVA 0.05-0.6).
- Amblyopia caused by anisometropia, strabismus, or both, meeting the following definitions:
- Anisometropic amblyopia: interocular spherical-equivalent difference ≥1.00 D or astigmatic difference ≥1.50 D in any meridian, with no manifest strabismus at distance or near.
- Strabismic amblyopia: strabismus at distance or near, or a history of strabismus surgery, without meeting the anisometropia criterion.
- Combined-mechanism amblyopia: meeting both the strabismus and anisometropia criteria.
- Completion of standardized optical correction and the 8-12-week stability period; absolute difference between week -4 and week 0 ETDRS scores <5 letters, with no continuing pretreatment improvement trend.
- Ability to use the study device for home training and accept electronic adherence monitoring.
Who cannot join
- Eccentric fixation, clinically significant nystagmus, or inability to complete reliable ETDRS testing.
- Corneal, lenticular, retinal, macular, optic-nerve, or neurologic disease capable of explaining the visual-acuity reduction.
- Study-eye spherical equivalent <-8.00 D, or high refractive error judged by the investigator to compromise test reliability.
- Recent intraocular surgery or ocular trauma, or extraocular-muscle surgery considered likely to affect outcomes.
- Diplopia at baseline that interferes with safety evaluation, or an unacceptable training risk as judged by the investigator.
- Patching, penalization, other visual training, or treatment likely to affect amblyopia outcomes within the prespecified period before randomization.
- Inability to complete follow-up, understand the tasks, or participation in another clinical study likely to affect outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
Yan Xu, (021)62982727-856, drxuyan_2004@163.com
About this study
This study is initiated and conducted by the Shanghai Eye Disease Prevention and Treatment Center / Shanghai Eye Hospital. Many people once believed that amblyopia (commonly known as "lazy eye") could only be treated during childhood (the critical period of visual development) and that nothing could be done once we reached adulthood. However, modern visual science research has revealed that the adult visual cortex still retains a certain degree of "neuroplasticity" (the brain's ability to reorganize, learn, and adapt). The Gabor target training used in this study-powered by RevitalVision software-is a scientifically proven visual training program. By repeatedly performing visual tasks near your perception threshold on a computer screen, this training exercises your eye-brain coordination, helping your brain process visual information much more efficiently.
To help you and your family participate with peace of mind, we have compiled the following answers to frequently asked questions:
Read more
Q1: How will I participate in this study? What is the difference between the two groups?
To scientifically compare the training's effectiveness, this study uses a rigorous randomized controlled design. A total of 80 eligible participants will be randomly assigned by a computer program in a 1:1 ratio to one of two groups:
Immediate Training Group:
You will begin the 12-week home-based Gabor visual training right after randomization. Your study participation ends after your Week 12 follow-up.
Delayed Training Group:
During the first 12 weeks after randomization, you will simply wear your prescribed glasses and go about your daily life without active visual training.
After completing your Week 12 eye evaluation, you will receive the exact same 12-week Gabor visual training for free (conducted from Week 12 to Week 24).
Please be assured: No matter which group you are assigned to, every eligible participant will ultimately receive the exact same 12-week professional visual training. This "delayed treatment" design is highly ethical. It ensures everyone gets treated while allowing us to compare the two groups transitionally during the first 12 weeks, thereby ruling out other factors like "getting used to the vision charts" or "gradually adjusting to new glasses".
Q2: How is the visual training performed? Is it difficult to do at home?
The training is fully home-based, meaning you do not need to visit the hospital constantly. However, it requires your dedication and, ideally, supervision from your family:
Training Tools: You will use the specialized RevitalVision perceptual learning software on a calibrated computer monitor.
Training Environment: The training should be done in a dark or standard low-light room. Your only main light source should be the computer screen, and you will sit exactly 1.5 meters away.
Glasses \& Patching: You must wear your prescribed study glasses during training. If you have monocular (one-sided) amblyopia, you will need to patch your stronger eye (non-study eye), using only your weaker eye (amblyopia eye) to view the screen.
Frequency \& Duration: You will train 4 times a week, for about 30 minutes per session, over a continuous span of 12 weeks. The software is adaptive: it automatically adjusts the difficulty of your next session based on your performance to keep you at your optimal training zone.
Q3: What do I need to do at the hospital during the study?
Your safety and visual health are our top priorities. We will provide meticulous, standardized eye examinations throughout the study:
Before the training begins, you will go through an 8- to 12-week "Refractive Stability Phase". During this time, we will perform cycloplegic refraction (dilation) and prescribe your glasses, checking your vision multiple times to ensure your baseline sight is completely stable.
During the study, you will only need to visit the clinic for follow-ups at Weeks 6 and 12 (the Delayed Group will also have visits at Weeks 18 and 24).
At these visits, our examiners (who do not know which group you are in to ensure objectivity) will measure your vision using standard ETDRS charts, evaluate your contrast sensitivity (using the computerized FrACT test), assess your stereoacuity (3D vision), and capture advanced 3D structural scans of your retina and choroid using Swept-Source OCT.
Q4: Is the training safe? What if my vision gets worse? The visual training is entirely physical and non-invasive, with an excellent safety record.
In very rare cases, some participants might experience mild, temporary eye strain, headaches, or slight discomfort when they first start training.
Double-Safety \& Rescue Protocols: We have set strict "rescue criteria". If at any point during your observation or training, your vision drops significantly or if you experience persistent double vision, we will immediately initiate a professional assessment. If necessary, we will halt the training and provide standard clinical medical care.
- Conditions
- Amblyopia, Anisometropia
- Being tested
- Gabor training
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabor trainingDevice
Gabor-Based Perceptual Learning:
Home-based training will use the RevitalVision visual perceptual-learning software. Training should be conducted in a dark or standardized low-illumination environment, with a calibrated computer display as the primary light source and a viewing distance of 1.5 m. Training modes include single-image, clarity, lateral-masking, and image-shift tasks, with parameters adaptively adjusted according to performance.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-Training Group | Active comparator | Not described Receives: Device: Gabor training |
| Delayed-Training Group | Other | Delayed-Training Group: Gabor-Based Perceptual Learning Home-based training will be delayed by 12 weeks. Receives: Device: Gabor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amblyopic-eye ETDRS letters
Measured: Change from randomized baseline in amblyopic-eye ETDRS letters at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start25 May 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiannan Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764198
- Sponsor's protocol ID
- 20250325.2.1
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Gabor-Based Perceptual Learning for Adult Amblyopia
- ClinicalTrials.gov ID
- NCT07764198
- Acronym / sponsor ID
- 20250325.2.1
- Conditions
- Amblyopia, Anisometropia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiannan HuangUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 2026 (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.
This study is initiated and conducted by the Shanghai Eye Disease Prevention and Treatment Center / Shanghai Eye Hospital. Many people once believed that amblyopia (commonly known as "lazy eye") could only be treated during childhood (the critical period of visual development) and that nothing could be done once we reached adulthood. However, modern visual science research has revealed that the adult visual cortex still retains a certain degree of "neuroplasticity" (the brain's ability to reorganize, learn, and adapt). The Gabor target training used in this study-powered by RevitalVision software-is a scientifically proven visual training program. By repeatedly performing visual tasks near your perception threshold on a computer screen, this training exercises your eye-brain coordination, helping your brain process visual information much more efficiently.
To help you and your family participate with peace of mind, we have compiled the following answers to frequently asked questions:
Q1: How will I participate in this study? What is the difference between the two groups?
To scientifically compare the training's effectiveness, this study uses a rigorous randomized controlled design. A total of 80 eligible participants will be randomly assigned by a computer program in a 1:1 ratio to one of two groups:
Immediate Training Group:
You will begin the 12-week home-based Gabor visual training right after randomization. Your study participation ends after your Week 12 follow-up.
Delayed Training Group:
During the first 12 weeks after randomization, you will simply wear your prescribed glasses and go about your daily life without active visual training.
After completing your Week 12 eye evaluation, you will receive the exact same 12-week Gabor visual training for free (conducted from Week 12 to Week 24).
Please be assured: No matter which group you are assigned to, every eligible participant will ultimately receive the exact same 12-week professional visual training. This "delayed treatment" design is highly ethical. It ensures everyone gets treated while allowing us to compare the two groups transitionally during the first 12 weeks, thereby ruling out other factors like "getting used to the vision charts" or "gradually adjusting to new glasses".
Q2: How is the visual training performed? Is it difficult to do at home?
The training is fully home-based, meaning you do not need to visit the hospital constantly. However, it requires your dedication and, ideally, supervision from your family:
Training Tools: You will use the specialized RevitalVision perceptual learning software on a calibrated computer monitor.
Training Environment: The training should be done in a dark or standard low-light room. Your only main light source should be the computer screen, and you will sit exactly 1.5 meters away.
Glasses \& Patching: You must wear your prescribed study glasses during training. If you have monocular (one-sided) amblyopia, you will need to patch your stronger eye (non-study eye), using only your weaker eye (amblyopia eye) to view the screen.
Frequency \& Duration: You will train 4 times a week, for about 30 minutes per session, over a continuous span of 12 weeks. The software is adaptive: it automatically adjusts the difficulty of your next session based on your performance to keep you at your optimal training zone.
Q3: What do I need to do at the hospital during the study?
Your safety and visual health are our top priorities. We will provide meticulous, standardized eye examinations throughout the study:
Before the training begins, you will go through an 8- to 12-week "Refractive Stability Phase". During this time, we will perform cycloplegic refraction (dilation) and prescribe your glasses, checking your vision multiple times to ensure your baseline sight is completely stable.
During the study, you will only need to visit the clinic for follow-ups at Weeks 6 and 12 (the Delayed Group will also have visits at Weeks 18 and 24).
At these visits, our examiners (who do not know which group you are in to ensure objectivity) will measure your vision using standard ETDRS charts, evaluate your contrast sensitivity (using the computerized FrACT test), assess your stereoacuity (3D vision), and capture advanced 3D structural scans of your retina and choroid using Swept-Source OCT.
Q4: Is the training safe? What if my vision gets worse? The visual training is entirely physical and non-invasive, with an excellent safety record.
In very rare cases, some participants might experience mild, temporary eye strain, headaches, or slight discomfort when they first start training.
Double-Safety \& Rescue Protocols: We have set strict "rescue criteria". If at any point during your observation or training, your vision drops significantly or if you experience persistent double vision, we will immediately initiate a professional assessment. If necessary, we will halt the training and provide standard clinical medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-Training Group | Active comparator | Device: Gabor training |
| Delayed-Training Group | Other | Device: Gabor trainingDelayed-Training Group: Gabor-Based Perceptual Learning Home-based training will be delayed by 12 weeks. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written informed consent; age 18-39 years inclusive at randomization.
- Diagnosis of amblyopia, with amblyopic-eye BCVA of approximately 20-70 ETDRS letters (approximately decimal BCVA 0.05-0.6).
- Amblyopia caused by anisometropia, strabismus, or both, meeting the following definitions:
- Anisometropic amblyopia: interocular spherical-equivalent difference ≥1.00 D or astigmatic difference ≥1.50 D in any meridian, with no manifest strabismus at distance or near.
- Strabismic amblyopia: strabismus at distance or near, or a history of strabismus surgery, without meeting the anisometropia criterion.
Key exclusion criteria (7 listed)
- Eccentric fixation, clinically significant nystagmus, or inability to complete reliable ETDRS testing.
- Corneal, lenticular, retinal, macular, optic-nerve, or neurologic disease capable of explaining the visual-acuity reduction.
- Study-eye spherical equivalent <-8.00 D, or high refractive error judged by the investigator to compromise test reliability.
- Recent intraocular surgery or ocular trauma, or extraocular-muscle surgery considered likely to affect outcomes.
- Diplopia at baseline that interferes with safety evaluation, or an unacceptable training risk as judged by the investigator.
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 |
|---|---|---|
| Gabor trainingGabor-Based Perceptual Learning: Home-based training will use the RevitalVision visual perceptual-learning software. Training should be conducted in a dark or standardized low-illumination environment, with a calibrated computer display as the primary light source and a viewing distance of 1.5 m. Training modes include single-image, clarity, lateral-masking, and image-shift tasks, with parameters adaptively adjusted according to performance. | Device | Delayed-Training Group, Immediate-Training Group |
Primary outcome
Change in amblyopic-eye ETDRS letters
Time frame: Change from randomized baseline in amblyopic-eye ETDRS letters at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabor training in people with Amblyopia and Anisometropia, run by Jiannan Huang at 1 site in China.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu (021-62982727-856, drxuyan_2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amblyopic-eye ETDRS letters (time frame: Change from randomized baseline in amblyopic-eye ETDRS letters at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.