Eye InjuriesNCT06174415
An Exploratory Study of Visual Function Rehabilitation in Patients With Ocular Trauma
A study testing Perceptual Learning in people with Eye Injuries, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Ocular trauma is one of the leading causes of blindness worldwide, often resulting in severe visual impairment or even loss of vision after injury. Although after powerful surgical treatment, there are still some patients whose visual function is difficult to improve, and the patients with eye trauma lack effective… Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Eye Injuries
- What is being tested?
- Perceptual Learning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2023to 30 Apr 2024
- 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Retinopathy, optic neuropathy, endophthalmitis and other injuries caused by ocular trauma, with varying degrees of central vision reduction and visual field impairment
- Age 3~60 years old
- Best corrected visual acuity of the affected eye: 20/200≤BCVA≤20/25
- Intraocular pressure is normal, non-hypotonal/atrophic: 7--21mmHg
- After the traumatic injury, the condition is stable ≥for 3 months after treatment, and the visual axis has a complete and transparent optical pathway
- If the patient is injured in one eye, There were no abnormal lesions in the contralateral eye, no abnormalities in slit lamp and indirect ophthalmoscopy, and no peripheral retinopathy in both eyes was found on triprimmoscopy. Carefully ask for a history of no other eye disease in both eyes and a systemic history that has caused an associated eye disease or has affected visual formation.
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- The cranial structure is intact, the function is good, and there is no primary or secondary injury
- Able to cooperate with the questionnaire and treatment, good compliance
- Those who are willing to sign the informed consent form
Who cannot join
- Have active inflammation of the eye
- Previous abnormal intraocular blood supply such as occlusion of the central intraocular artery due to trauma or non-traumatic factors
- History of other non-traumatic intraocular surgery
- Ocular related lesions caused by other non-traumatic factors that can interfere with this study, such as age-related macular degeneration, glaucoma, amblyopia, etc.
- Use of other rehabilitation training methods or visual aids 3 months before enrollment
- Lesions with systemic diseases whose degree of lesions have affected visual function, such as diabetic retinopathy, Hypertension and arteriosclerotic fundus changes, rubella-related ocular changes, etc.
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- Patients with severe systemic diseases such as renal failure and malignant hypertension or may affect visual function (such as retinal structure and function, choroidal structure and function, etc.)
- Patients with congenital ocular lesions
- Patients with optic nerve and retinopathy caused by non-traumatic factors
- Patients with cranial brain disease or craniocere-related lesions with poor cortical function
- Psychological related diseases
- MRI contraindications, Such as claustrophobia and non-MRI compatible metal implants
- people with speech impairment and intellectual disability
- those who are considered inappropriate by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Zhonshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong
WANQI QIAN, 0086-15765304712, qianwanqi618@gmail.com
About this study
Ocular trauma is one of the leading causes of blindness worldwide, often resulting in severe visual impairment or even loss of vision after injury.
Although after powerful surgical treatment, there are still some patients whose visual function is difficult to improve, and the patients with eye trauma lack effective vision rehabilitation therapy.Therefore, the research on visual function rehabilitation of patients with ocular trauma needs to be further carried out . Perceptual learning is based on cortical remodeling, repetitive visual task training. This training is to perform a series of repetitive visual tasks through the Gabor patch, simulating the receptive field structure of simple cells in the primary visual cortex (V1 area), "awakening visual cells", and improving the visual processing ability of the cerebral cortex. Compared with the traditional vision rehabilitation therapy, perceptual learning optimizes the visual quality at the visual center level. It is an innovative therapy, having the potential to solve the visual function of patients with eye trauma. This study intends to explore new visual rehabilitation methods for patients with ocular trauma, and explore the changes in visual cortical function and area of patients after perceptual training.
Read the detailed description
Perceptual training is a type of perceptual learning that initiates neural modifications during continuous repetitive task training, thereby increasing neural efficiency and improving the visual processing capabilities of the cerebral cortex. The perceptual training program simulates the receptive field structure of simple cells in the primary visual cortex (area V1) through Gabor cursors and lateral occlusion techniques to awaken visual cells during repetitive visual tasks. Gabor Patches are targeted stimuli that are widely used in the field of optic neurology to produce highly effective stimulation of the primary visual cortex. Lateral shading technology can effectively stimulate specific neurons. It can not only improve the interaction of neurons in the cerebral cortex in patients with amblyopia, but also stimulate the cooperation of neurons. This technology has also been proved to be effective in normal people. Therefore, on the basis of this theory, we plan to use perceptual learning to conduct repetitive visual stimulation for three months, and return to visit three times within three months. The main indicator is contrast sensitivity, and the efficacy of perceptual learning is evaluated by evaluating the improvement of contrast sensitivity. The study was designed as a self-controlled before-and-after trial. Volunteers were recruited from the outpatients of Zhongshan Ophthalmic Center's ophthalmic trauma clinic to participate in the study.
- Conditions
- Eye Injuries
- Being tested
- Perceptual Learning
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual LearningDevice
Perceptual training is carried out at home once a day, and the viewing distance of the patients from the display screen is uniformly 1.5m, 30 minutes each time, for three months, and they return to the hospital for re-examination of ophthalmology at the 3rd months after the training. When using the perceptual training program for the first time, the training program will adjust the size of the Gabor spot according to the size of the user's computer, and prompt the patient to adjust the brightness of the computer screen to unify the Gabor spot parameters of each user and ensure the consistency of the spot stimulation information received by each user.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group consisted of the patients themselves. Compare data before and after treatment Receives: Device: Perceptual Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Log MAR
Measured: 3 months
Secondary outcomes (1)
Contrast Sensitivity Function
Area Under the Log Contrast Sensitivity Function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InjuriesStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Model description
- Comparing the data before and after treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XUEYING ZHONGLIU, Study director, Zhonshan Ophthalmic Center, Sun-Yat-sen University Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174415
- Sponsor's protocol ID
- 2023KYPJ122
- Status last verified
- May 2023
- First submitted
- 8 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Visual Function Rehabilitation in Patients With Ocular Trauma
- ClinicalTrials.gov ID
- NCT06174415
- Acronym / sponsor ID
- 2023KYPJ122
- Conditions
- Eye Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 18 Dec 2023 (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.
Ocular trauma is one of the leading causes of blindness worldwide, often resulting in severe visual impairment or even loss of vision after injury.
Although after powerful surgical treatment, there are still some patients whose visual function is difficult to improve, and the patients with eye trauma lack effective vision rehabilitation therapy.Therefore, the research on visual function rehabilitation of patients with ocular trauma needs to be further carried out . Perceptual learning is based on cortical remodeling, repetitive visual task training. This training is to perform a series of repetitive visual tasks through the Gabor patch, simulating the receptive field structure of simple cells in the primary visual cortex (V1 area), "awakening visual cells", and improving the visual processing ability of the cerebral cortex. Compared with the traditional vision rehabilitation therapy, perceptual learning optimizes the visual quality at the visual center level. It is an innovative therapy, having the potential to solve the visual function of patients with eye trauma. This study intends to explore new visual rehabilitation methods for patients with ocular trauma, and explore the changes in visual cortical function and area of patients after perceptual training.
Detailed description
Perceptual training is a type of perceptual learning that initiates neural modifications during continuous repetitive task training, thereby increasing neural efficiency and improving the visual processing capabilities of the cerebral cortex. The perceptual training program simulates the receptive field structure of simple cells in the primary visual cortex (area V1) through Gabor cursors and lateral occlusion techniques to awaken visual cells during repetitive visual tasks. Gabor Patches are targeted stimuli that are widely used in the field of optic neurology to produce highly effective stimulation of the primary visual cortex. Lateral shading technology can effectively stimulate specific neurons. It can not only improve the interaction of neurons in the cerebral cortex in patients with amblyopia, but also stimulate the cooperation of neurons. This technology has also been proved to be effective in normal people. Therefore, on the basis of this theory, we plan to use perceptual learning to conduct repetitive visual stimulation for three months, and return to visit three times within three months. The main indicator is contrast sensitivity, and the efficacy of perceptual learning is evaluated by evaluating the improvement of contrast sensitivity. The study was designed as a self-controlled before-and-after trial. Volunteers were recruited from the outpatients of Zhongshan Ophthalmic Center's ophthalmic trauma clinic to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparing the data before and after treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Perceptual LearningThe experimental group consisted of the patients themselves. Compare data before and after treatment |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Retinopathy, optic neuropathy, endophthalmitis and other injuries caused by ocular trauma, with varying degrees of central vision reduction and visual field impairment
- Age 3~60 years old
- Best corrected visual acuity of the affected eye: 20/200≤BCVA≤20/25
- Intraocular pressure is normal, non-hypotonal/atrophic: 7--21mmHg
- After the traumatic injury, the condition is stable ≥for 3 months after treatment, and the visual axis has a complete and transparent optical pathway
Key exclusion criteria (14 listed)
- Have active inflammation of the eye
- Previous abnormal intraocular blood supply such as occlusion of the central intraocular artery due to trauma or non-traumatic factors
- History of other non-traumatic intraocular surgery
- Ocular related lesions caused by other non-traumatic factors that can interfere with this study, such as age-related macular degeneration, glaucoma, amblyopia, etc.
- Use of other rehabilitation training methods or visual aids 3 months before enrollment
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 |
|---|---|---|
| Perceptual LearningPerceptual training is carried out at home once a day, and the viewing distance of the patients from the display screen is uniformly 1.5m, 30 minutes each time, for three months, and they return to the hospital for re-examination of ophthalmology at the 3rd months after the training. When using the perceptual training program for the first time, the training program will adjust the size of the Gabor spot according to the size of the user's computer, and prompt the patient to adjust the brightness of the computer screen to unify the Gabor spot parameters of each user and ensure the consistency of the spot stimulation information received by each user. | Device | Experimental group |
Primary outcome
Best Corrected Visual Acuity
Time frame: 3 months
Log MAR
1 secondary outcome
Contrast Sensitivity Function
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- 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.
XUEYING ZHONGLIU study director
Zhonshan Ophthalmic Center, Sun-Yat-sen University Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual Learning in people with Eye Injuries, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WANQI QIAN (0086-15765304712, qianwanqi618@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 3 months). 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 18 Dec 2023.