Visual Field DefectsNCT06914505
Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects
A study testing visual restoration therapy in people with Visual Field Defects and Visual Field Loss, run by Xuanwu Hospital, Beijing.
Trial summary
The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Visual Field Defects, Visual Field Loss
- What is being tested?
- visual restoration therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 30 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a clear diagnosis of visual field defects.
- Participants were between 18 and 80 years of age (including borderline values);
- Participants have been treated for their primary disease and conditions are stable;
- Participants are not at significant risk of vision loss in the last three months;
- Participants do not have planned intraocular surgery during the trial period；
- Participants can understand the trial protocol and sign informed consent.
Who cannot join
- Participants diagnosed as blindness;
- Participants with a previous history of seizures or other psychiatric disorders;
- Participants with cognitive impairments;
- Participant's attention span is less than 30 minutes;
- Participants had conditions such as significant ptosis or severe dry eye;
- Participants who were in poor general health or who could not cooperate in completing the study protocol for some reasons such as transport.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Effectiveness and Safety of Visual Restoration Therapy in the Active Rehabilitation of Patients With Visual Field Defects
The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. The main questions it aims to answer are:
- Can visual reconstruction therapy help expand the visual field in patients with visual field defects?
- What medical problems do patients with visual field defects experience during the procedure of VRT? Researchers will look at how patients with visual field defects who use a visual aid in combination with VRT and those who use a visual aid only, compare the visual field expansion at three months to see how well visual reconstruction therapy works.
Read more
Participants will:
- will undergo a specialized visual function assessment and be provided with a pair of appropriate vision aids.
- Visit the clinic at one month and three months after enrolment for review of visual function and completion of a Chinese-version Low Vision Quality of Life (CLVQOL) questionnaire.
- Participants receiving VRT will additionally undergo 30 minutes of VRT three times per week for 3 months.
- Keep a diary for their symptoms and severity and frequency of occurrence during treatment.
- Conditions
- Visual Field Defects, Visual Field Loss
- Being tested
- visual restoration therapy
- Keywords
- visual field defect, visual restoration therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual restoration therapyBehavioural
Also called photostimulation therapy
In this study, we used a reversing checkerboard pattern as a stimulus and acted on the relatively dark spots area of the patient's visual field.
| Study group | Role | What they receive |
|---|---|---|
| VRT treatment group | Experimental | The participants will be provided with a pair of appropriate vision aids and will undergo 3 times 30-minute visual restoration therapy (VRT) training per week for three months. Receives: Behavioral: visual restoration therapy |
| control group | No intervention | Participants will be provided with a pair of appropriate vision aids, however without any visual treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual field mean deviation (MD) value
using the Humphrey Field Analyzer 30-2 test to obtain MD values
Measured: A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Field DefectsStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen Li, MD. and PHD., Principal investigator, Ophthalmology Department, Xuanwu Hospital，Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914505
- Sponsor's protocol ID
- LYS2024211001
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Visual Restoration Therapy in the Active Rehabilitation of Patients With Visual Field Defects
- ClinicalTrials.gov ID
- NCT06914505
- Acronym / sponsor ID
- LYS2024211001
- Conditions
- Visual Field Defects, Visual Field Loss
- Keywords
- visual field defect, visual restoration therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Apr 2025 (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.
The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. The main questions it aims to answer are:
- Can visual reconstruction therapy help expand the visual field in patients with visual field defects?
- What medical problems do patients with visual field defects experience during the procedure of VRT? Researchers will look at how patients with visual field defects who use a visual aid in combination with VRT and those who use a visual aid only, compare the visual field expansion at three months to see how well visual reconstruction therapy works.
Participants will:
- will undergo a specialized visual function assessment and be provided with a pair of appropriate vision aids.
- Visit the clinic at one month and three months after enrolment for review of visual function and completion of a Chinese-version Low Vision Quality of Life (CLVQOL) questionnaire.
- Participants receiving VRT will additionally undergo 30 minutes of VRT three times per week for 3 months.
- Keep a diary for their symptoms and severity and frequency of occurrence during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRT treatment group | Experimental | Behavioral: visual restoration therapyThe participants will be provided with a pair of appropriate vision aids and will undergo 3 times 30-minute visual restoration therapy (VRT) training per week for three months. |
| control group | No intervention | –Participants will be provided with a pair of appropriate vision aids, however without any visual treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with a clear diagnosis of visual field defects.
- Participants were between 18 and 80 years of age (including borderline values);
- Participants have been treated for their primary disease and conditions are stable;
- Participants are not at significant risk of vision loss in the last three months;
- Participants do not have planned intraocular surgery during the trial period；
Key exclusion criteria (6 listed)
- Participants diagnosed as blindness;
- Participants with a previous history of seizures or other psychiatric disorders;
- Participants with cognitive impairments;
- Participant's attention span is less than 30 minutes;
- Participants had conditions such as significant ptosis or severe dry eye;
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 |
|---|---|---|
| visual restoration therapyAlso: photostimulation therapyIn this study, we used a reversing checkerboard pattern as a stimulus and acted on the relatively dark spots area of the patient's visual field. | Behavioural | VRT treatment group |
Primary outcome
visual field mean deviation (MD) value
Time frame: A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.
using the Humphrey Field Analyzer 30-2 test to obtain MD values
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 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Visual Field Defects
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Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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Impact of Glaucoma and Visual Field Loss on Life Space
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Statistical Learning as a Novel Intervention for Cortical Blindness
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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.
Zhen Li, MD. and PHD. principal investigator
Ophthalmology Department, Xuanwu Hospital，Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing visual restoration therapy in people with Visual Field Defects and Visual Field Loss, run by Xuanwu Hospital, Beijing.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhen Li, MD. and PHD. (+86 13581646689, zhenli_xwyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual field mean deviation (MD) value (time frame: A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.). 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 6 Apr 2025.