GlaucomaNCT06076720
Evaluation of New Head-mounted Visual Aids Among Patients With Low Vision
A study testing New head-mounted visual aids in people with Glaucoma and Age-related Macular Degeneration, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa, RP, diabetic retinopathy (DR) are the most common blinding eye diseases in the world. Vision and visual field are often severely impaired, quality of life is reduced, and personal and family burdens are heavy. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Glaucoma, Age-related Macular Degeneration, Retinitis Pigmentosa
- What is being tested?
- New head-mounted visual aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 10 Oct 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age ≥10 years, able to complete all tests and inspections
- a definite diagnosis of low vision or blindness:
- Criteria for low vision: the best corrected visual acuity of the better eye ≤0.3, and ≥0.05 or the visual field of the better eye no greater than 20° in radius around central fixation
- Criteria for blindness: the best corrected visual acuity of the better eye <0.05 or the visual field of the better eye no greater than 10° in radius around central fixation
- Visual acuity, intraocular pressure, and other eye conditions have been stable for more than 6 months.
Who cannot join
- unable to cooperate with related inspections
- a history of eye surgery or eye laser within six months
- serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc.
- pregnant or lactating women
- those who refuse to sign the informed consent or voluntarily withdraw from the study due to discomfort or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Zhuoyehong Zhuo, 13352828998, zhuoyh@mail.sysu.edu.cn
About this study
Glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa, RP, diabetic retinopathy (DR) are the most common blinding eye diseases in the world. Vision and visual field are often severely impaired, quality of life is reduced, and personal and family burdens are heavy. This kind of low vision people, can use visual AIDS and other instruments for visual rehabilitation training, maximize the function of residual vision, improve the quality of life. Beyes, HOLA, Acesight and OXSIGHT are among the latest eyeglasses devices that are expected to improve the quality of life for people with low vision. This research group intends to recruit advanced patients with primary glaucoma, AMD, RP, DR and other common blinding eye diseases who visited Zhongshan Ophthalmology Center of Sun Yat-sen University from June 2021 to December 2022 to study the changes of visual function and quality of life after wearing this new type of head-worn visual aids, and analyze relevant factors combined with clinical data. To evaluate the effect and influencing factors of the new head-mounted visual AIDS on patients, and provide theoretical basis for subsequent clinical research.
Read the detailed description
- Low vision Low visual acuity refers to a patient who has functional impairment of vision even after treatment or standard refractive correction. The visual acuity of the good middle eye in both eyes is less than 0.3, or the field radius is ≤20°, but still has the ability to use the remaining vision to perform a certain visual activity. In China, low vision caused by eye diseases (such as glaucoma, AMD, RP, DR) can lead to behavioral loss of patients, and standardized rehabilitation treatment of low vision can help 90% of visual impairment patients improve the utilization rate of residual vision, becoming an important way to compensate for the loss of visual function of this group.
- Visual rehabilitation of low vision The latest definition of visual rehabilitation is a kind of multidisciplinary comprehensive rehabilitation therapy. By ophthalmologists, depending on the light, low vision devices, low vision rehabilitation counselors professional therapists, social workers and psychologists of the multidisciplinary team, using physical, audio, electronic, optical instruments, and life skills training, help patients with low vision to use its residual vision and development skills available to offset the impact of visual impairment in patients, To improve their self-living ability and quality of life. There are three treatment levels: discovery, guidance and referral; Individual rehabilitation; Multidisciplinary visual rehabilitation. The first step of visual rehabilitation is often accurate optometry in order to obtain the best corrected vision, which is also an important basis for the success of visual rehabilitation. On the basis of refractive correction, it can obviously improve the daily living ability and quality of life of the patients with low vision by providing them with appropriate visual aids and corresponding training of using visual aids. Visual aids are generally divided into near-use and far-use visual aids, in which near-vision and reading ability are the focus of functional vision assessment and rehabilitation. Traditional used visual aids have hand-held magnifier, vertical magnifier, glasses and electronic visual aids. Compared with optical visual aids, electronic visual aids have the advantages of clear imaging, adjustable magnification and contrast.
- Research status of smart wearable devices Traditional visual AIDS achieve the effect of object image amplification through the principle of optics, but have fixed magnification rate, reduced field of vision, small depth of field, short working distance, can not adjust the contrast and other shortcomings. In recent years, video wearable devices have been gradually applied in the field of visual rehabilitation, with the advantages of adjustable magnification, adjustable contrast and high clarity, overcoming the limitations of traditional optical devices, including eSight 3, NuEyes, IrisVision, etc.
Currently, there are few studies on wearable electronic visual aids. Walter Wittich et al. conducted an intervention trial on 51 patients with low vision and confirmed that wearable electronic visual aids can improve patients' visual acuity, spatial object recognition ability, and reading and activity ability. In the study of middle-advanced glaucoma, Yogesh Patodia et al. found that wearable electronic visual aids can also improve their long-range and near-range vision.
Smart glasses such as Beyes, HOLA, Acesight and OXSIGHT are the latest wearable electronic visual aids to hit the market, featuring advantages of lighter weight, comfortable wearing, better imaging quality and multi-mode assisted visual recognition. However, the effect and influencing factors of this kind of smart glasses on advanced patients with glaucoma, AMD, RP, DR and other common blinding eye diseases are still unclear, which requires further exploration by researchers.
- Being tested
- New head-mounted visual aids
- Keywords
- Visual rehabilitation of low vision, head-mounted devices
- Medical subject headings
- Glaucoma, Macular Degeneration, Retinitis Pigmentosa, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New head-mounted visual aidsDevice
New head-mounted visual aids such as Beyes, HOLA, Acesight and OXSIGHT are the latest wearable electronic visual aids
| Study group | Role | What they receive |
|---|---|---|
| New head-mounted visual aids | Experimental | Wearing different head-mounted visual aids Receives: Device: New head-mounted visual aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of changes in the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) scores at different time points
The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in the National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) scores at different time points
The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in the Low Vision Quality-of-Life Questionnaire (LVQOL) scores at different time points
The Low Vision Quality-of-Life Questionnaire (LVQOL) specifically examines the QOL of patients with visual disability. The LVQOL is of the latter type, with the 25 items producing a summed score between 0 and 125 (the higher the score, the higher the quality of life). The 25 items are grouped into 4 subscales: distance vision, mobility and lighting; adjustment; reading and fine work; and daily life activities. As a convenient tool, LVQOL is widely used in clinical settings to evaluate effects of clinical treatment and corresponding strategies of low-vision rehabilitation. The LVQOL was tested at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Secondary outcomes (6)
Comparison of changes in visual acuity at different time points
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart was used. The examination was performed at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in contrast sensitivity at different time points
Pelli-Robson Contrast Sensitivity Charts were used. The examination was performed at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in kinetic visual field at different time points
Kinetic visual field was measured by the automated perimetry. The examination was performed at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in functional magnetic resonance imaging (MRI) at different time points
The whole brain BOLD and T1 structures were scanned using a MAGNETOM Verio 3 T MR scanner. Structural and functional MRI scans were performed at baseline and at 1 week, 8 weeks, and 6 months after intervention.
Measured: 6 months after intervention
Comparison of changes in mobility test at different time points
A mobility test was performed to evaluate patients' functionality in 2 scenarios: using their presenting distance visual acuity with no aids and using the head-mounted aids. A loop-shaped obstacle course consisting of stationary obstacles from floor to head level was designed for this test. The test was performed at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Comparison of changes in visual scanning test at different time points
A visual scanning test was performed to evaluate patients' functionality in 2 scenarios: using their presenting distance visual acuity with no aids and using the head-mounted aids. Four pictures were designed for this test. Each picture involved seven types of randomly aligned figures and the four patterns of pictures with different alignments were prepared to determine the scores of individuals and the time required to answer. The test was performed at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Measured: 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start10 Oct 2023 (estimated)
- Primary completion10 Aug 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076720
- Sponsor's protocol ID
- 2021KYPJ123
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available.
PubMed 29108747
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Head-mounted Visual Aids Among Patients With Low Vision
- ClinicalTrials.gov ID
- NCT06076720
- Acronym / sponsor ID
- 2021KYPJ123
- Keywords
- Visual rehabilitation of low vision, head-mounted devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (estimated)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 11 Oct 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.
Glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa, RP, diabetic retinopathy (DR) are the most common blinding eye diseases in the world. Vision and visual field are often severely impaired, quality of life is reduced, and personal and family burdens are heavy. This kind of low vision people, can use visual AIDS and other instruments for visual rehabilitation training, maximize the function of residual vision, improve the quality of life. Beyes, HOLA, Acesight and OXSIGHT are among the latest eyeglasses devices that are expected to improve the quality of life for people with low vision. This research group intends to recruit advanced patients with primary glaucoma, AMD, RP, DR and other common blinding eye diseases who visited Zhongshan Ophthalmology Center of Sun Yat-sen University from June 2021 to December 2022 to study the changes of visual function and quality of life after wearing this new type of head-worn visual aids, and analyze relevant factors combined with clinical data. To evaluate the effect and influencing factors of the new head-mounted visual AIDS on patients, and provide theoretical basis for subsequent clinical research.
Detailed description
- Low vision Low visual acuity refers to a patient who has functional impairment of vision even after treatment or standard refractive correction. The visual acuity of the good middle eye in both eyes is less than 0.3, or the field radius is ≤20°, but still has the ability to use the remaining vision to perform a certain visual activity. In China, low vision caused by eye diseases (such as glaucoma, AMD, RP, DR) can lead to behavioral loss of patients, and standardized rehabilitation treatment of low vision can help 90% of visual impairment patients improve the utilization rate of residual vision, becoming an important way to compensate for the loss of visual function of this group.
- Visual rehabilitation of low vision The latest definition of visual rehabilitation is a kind of multidisciplinary comprehensive rehabilitation therapy. By ophthalmologists, depending on the light, low vision devices, low vision rehabilitation counselors professional therapists, social workers and psychologists of the multidisciplinary team, using physical, audio, electronic, optical instruments, and life skills training, help patients with low vision to use its residual vision and development skills available to offset the impact of visual impairment in patients, To improve their self-living ability and quality of life. There are three treatment levels: discovery, guidance and referral; Individual rehabilitation; Multidisciplinary visual rehabilitation. The first step of visual rehabilitation is often accurate optometry in order to obtain the best corrected vision, which is also an important basis for the success of visual rehabilitation. On the basis of refractive correction, it can obviously improve the daily living ability and quality of life of the patients with low vision by providing them with appropriate visual aids and corresponding training of using visual aids. Visual aids are generally divided into near-use and far-use visual aids, in which near-vision and reading ability are the focus of functional vision assessment and rehabilitation. Traditional used visual aids have hand-held magnifier, vertical magnifier, glasses and electronic visual aids. Compared with optical visual aids, electronic visual aids have the advantages of clear imaging, adjustable magnification and contrast.
- Research status of smart wearable devices Traditional visual AIDS achieve the effect of object image amplification through the principle of optics, but have fixed magnification rate, reduced field of vision, small depth of field, short working distance, can not adjust the contrast and other shortcomings. In recent years, video wearable devices have been gradually applied in the field of visual rehabilitation, with the advantages of adjustable magnification, adjustable contrast and high clarity, overcoming the limitations of traditional optical devices, including eSight 3, NuEyes, IrisVision, etc.
Currently, there are few studies on wearable electronic visual aids. Walter Wittich et al. conducted an intervention trial on 51 patients with low vision and confirmed that wearable electronic visual aids can improve patients' visual acuity, spatial object recognition ability, and reading and activity ability. In the study of middle-advanced glaucoma, Yogesh Patodia et al. found that wearable electronic visual aids can also improve their long-range and near-range vision.
Smart glasses such as Beyes, HOLA, Acesight and OXSIGHT are the latest wearable electronic visual aids to hit the market, featuring advantages of lighter weight, comfortable wearing, better imaging quality and multi-mode assisted visual recognition. However, the effect and influencing factors of this kind of smart glasses on advanced patients with glaucoma, AMD, RP, DR and other common blinding eye diseases are still unclear, which requires further exploration by researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New head-mounted visual aids | Experimental | Device: New head-mounted visual aidsWearing different head-mounted visual aids |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥10 years, able to complete all tests and inspections
- a definite diagnosis of low vision or blindness:
- Visual acuity, intraocular pressure, and other eye conditions have been stable for more than 6 months.
Key exclusion criteria (5 listed)
- unable to cooperate with related inspections
- a history of eye surgery or eye laser within six months
- serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc.
- pregnant or lactating women
- those who refuse to sign the informed consent or voluntarily withdraw from the study due to discomfort or other reasons.
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 |
|---|---|---|
| New head-mounted visual aidsNew head-mounted visual aids such as Beyes, HOLA, Acesight and OXSIGHT are the latest wearable electronic visual aids | Device | New head-mounted visual aids |
Primary outcome
Comparison of changes in the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) scores at different time points
Time frame: 8 weeks after intervention
The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Comparison of changes in the National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) scores at different time points
Time frame: 8 weeks after intervention
The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
Comparison of changes in the Low Vision Quality-of-Life Questionnaire (LVQOL) scores at different time points
Time frame: 8 weeks after intervention
The Low Vision Quality-of-Life Questionnaire (LVQOL) specifically examines the QOL of patients with visual disability. The LVQOL is of the latter type, with the 25 items producing a summed score between 0 and 125 (the higher the score, the higher the quality of life). The 25 items are grouped into 4 subscales: distance vision, mobility and lighting; adjustment; reading and fine work; and daily life activities. As a convenient tool, LVQOL is widely used in clinical settings to evaluate effects of clinical treatment and corresponding strategies of low-vision rehabilitation. The LVQOL was tested at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.
6 secondary outcomes
Comparison of changes in visual acuity at different time points
Time frame: 8 weeks after intervention
Comparison of changes in contrast sensitivity at different time points
Time frame: 8 weeks after intervention
Comparison of changes in kinetic visual field at different time points
Time frame: 8 weeks after intervention
Comparison of changes in functional magnetic resonance imaging (MRI) at different time points
Time frame: 6 months after intervention
Comparison of changes in mobility test at different time points
Time frame: 8 weeks after intervention
Comparison of changes in visual scanning test at different time points
Time frame: 8 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Results publication: PubMed 29108747Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available.
- Vision Rehabilitation Preferred Practice Pattern®Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New head-mounted visual aids in people with Glaucoma and Age-related Macular Degeneration, 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 5 inclusion and 5 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 11 Oct 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 Yehong Zhuo (13352828998, zhuoyh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of changes in the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) scores at different time points (time frame: 8 weeks after intervention). The study lists 3 primary outcomes in all. 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 NCT06076720, which also lists 1 linked publication.
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 11 Oct 2023.