Advanced GlaucomaOXSIGHTNCT04434612
Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
A study testing OXSIGHT smart glasses in people with Advanced Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
Glaucoma is the leading cause of irreversible blindness worldwide. The visual function of patients with advanced glaucoma is severely impaired, and the vision-related activities (e.g. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Advanced Glaucoma
- What is being tested?
- OXSIGHT smart glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2020to 31 Dec 2021
- 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 primary or secondary glaucoma or glaucoma in children;
- the best corrected visual acuity of the better eye is no more than 0.3 and better than 0.05; visual field ≤10° and MD value < -12db;
- 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 6 months;
- diseases that interfere with the diagnosis of glaucoma, such as optic disc dysplasia, obvious anisometropia, retinal vascular diseases, optic nerve diseases, macular degeneration, cerebrovascular diseases, 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
No sites are listed yet.
About this study
Glaucoma is the leading cause of irreversible blindness worldwide. The visual function of patients with advanced glaucoma is severely impaired, and the vision-related activities (e.g. movement, reading) are obviously restricted, which may have a negative impact on the patients' quality of life (QOL) and increase the burden on individuals and families. Low vision aids (LVAs) and other devices for vision rehabilitation (VR) are useful for patients with advanced glaucoma to maximize the function of residual vision and improve the QOL. OXSIGHT smart glasses are the latest LVAs eyeglasses that are expected to improve the QOL for patients with low vision (LV), such as those with glaucoma. Clinical data were collected to evaluate the efficacy and its influencing factors of OXSIGHT smart glasses in patients with advanced glaucoma, in providing theoretical basis for subsequent clinical studies.
Read the detailed description
- Glaucomatous low vision. Glaucoma is a chronic eye disease that causes irreversible damage to the optic nerve and can lead to severe vision loss and blindness. Low vision (LV) is a decrease in vision that cannot be corrected with standard glasses, contact lenses, medication or surgery, impairing a person's ability to perform age-appropriate vision-dependent tasks.
- Low vision rehabilitation. Low Vision Rehabilitation (LVR) is part of the continuum of eye care that extends from diagnosis to treatment and rehabilitation, designed to help visually impaired patients retain vision to the maximum, make activities easier to perform, regain independence, and improve their QOL. LVR services include comprehensive assessment of visual function, prescription of LVAs, rehabilitation training and referrals to a range of community services and psychosocial support.
- Research status of intelligent head-mounted devices. In recent years, video head-mounted devices have been gradually applied in the field of VR, with the advantages of high definition, diverse processing modes, adjustable magnification, contrast and brightness, which overcome the limitations of traditional devices, like eSight 3, NuEyes, and IrisVision. However, studies on the effectiveness of head-mounted electronic LVAs are quite limited.
- OXSIGHT smart glasses. OXSIGHT smart glasses, the latest generation of head-mounted electronic LVAs, developed by the team of Oxford University in the UK, are designed for LV patients with visual field defects. Based on the previous generation, OXSIGHT has the advantages of lighter weight, comfortable wearing, better imaging quality, multi-mode assisted visual recognition and so on. However, the efficacy and influencing factors of OXSIGHT smart glasses on advanced glaucoma patients remain unclear, and further studies are needed.
- Conditions
- Advanced Glaucoma
- Being tested
- OXSIGHT smart glasses
- Keywords
- OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXSIGHT smart glassesDevice
Also called There is no
OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
| Study group | Role | What they receive |
|---|---|---|
| OXSIGHT smart glasses | Experimental | Wearing OXSIGHT smart glasses Receives: Device: OXSIGHT smart glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline CLVQOL scores at different time points
The Low vision Quality of Life Questionnaire (LVQOL) specifically investigates the QOL of visually impaired patients. The questionnaire consists of 25 closed items and examines four dimensions: distance vision, mobility and lighting; adjustment; reading and fine work; daily 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. CLVQOL is the Chinese version of LVQOL.
Measured: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Secondary outcomes (4)
Changes from baseline visual acuity at different time points
ETDRS visual acuity chart was used.
Measured: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline contrast sensitivity at different time points
Pelli-Robson Contrast Sensitivity Charts were used.
Measured: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline visual field at different time points
Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
Measured: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline scores of mobility test at different time points
A mobility test was performed to evaluate patients' functionality in 2 scenarios: using their best-corrected visual acuity with no LVAs and using the OXSIGHT Smart Glasses. A loop-shaped obstacle course consisting of stationary obstacles from floor to head level was designed for this test.
Measured: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 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 posted17 Jun 2020
- Study start6 Jun 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434612
- Sponsor's protocol ID
- zhongshanOCOXSIGHT
- Acronym
- OXSIGHT
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.
PubMed 11673287Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
- ClinicalTrials.gov ID
- NCT04434612
- Acronym / sponsor ID
- OXSIGHT / zhongshanOCOXSIGHT
- Conditions
- Advanced Glaucoma
- Keywords
- OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Jun 2020 (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 is the leading cause of irreversible blindness worldwide. The visual function of patients with advanced glaucoma is severely impaired, and the vision-related activities (e.g. movement, reading) are obviously restricted, which may have a negative impact on the patients' quality of life (QOL) and increase the burden on individuals and families. Low vision aids (LVAs) and other devices for vision rehabilitation (VR) are useful for patients with advanced glaucoma to maximize the function of residual vision and improve the QOL. OXSIGHT smart glasses are the latest LVAs eyeglasses that are expected to improve the QOL for patients with low vision (LV), such as those with glaucoma. Clinical data were collected to evaluate the efficacy and its influencing factors of OXSIGHT smart glasses in patients with advanced glaucoma, in providing theoretical basis for subsequent clinical studies.
Detailed description
- Glaucomatous low vision. Glaucoma is a chronic eye disease that causes irreversible damage to the optic nerve and can lead to severe vision loss and blindness. Low vision (LV) is a decrease in vision that cannot be corrected with standard glasses, contact lenses, medication or surgery, impairing a person's ability to perform age-appropriate vision-dependent tasks.
- Low vision rehabilitation. Low Vision Rehabilitation (LVR) is part of the continuum of eye care that extends from diagnosis to treatment and rehabilitation, designed to help visually impaired patients retain vision to the maximum, make activities easier to perform, regain independence, and improve their QOL. LVR services include comprehensive assessment of visual function, prescription of LVAs, rehabilitation training and referrals to a range of community services and psychosocial support.
- Research status of intelligent head-mounted devices. In recent years, video head-mounted devices have been gradually applied in the field of VR, with the advantages of high definition, diverse processing modes, adjustable magnification, contrast and brightness, which overcome the limitations of traditional devices, like eSight 3, NuEyes, and IrisVision. However, studies on the effectiveness of head-mounted electronic LVAs are quite limited.
- OXSIGHT smart glasses. OXSIGHT smart glasses, the latest generation of head-mounted electronic LVAs, developed by the team of Oxford University in the UK, are designed for LV patients with visual field defects. Based on the previous generation, OXSIGHT has the advantages of lighter weight, comfortable wearing, better imaging quality, multi-mode assisted visual recognition and so on. However, the efficacy and influencing factors of OXSIGHT smart glasses on advanced glaucoma patients remain unclear, and further studies are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OXSIGHT smart glasses | Experimental | Device: OXSIGHT smart glassesWearing OXSIGHT smart glasses |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥10 years, able to complete all tests and inspections;
- a definite diagnosis of primary or secondary glaucoma or glaucoma in children;
- the best corrected visual acuity of the better eye is no more than 0.3 and better than 0.05; visual field ≤10° and MD value < -12db;
- 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 6 months;
- diseases that interfere with the diagnosis of glaucoma, such as optic disc dysplasia, obvious anisometropia, retinal vascular diseases, optic nerve diseases, macular degeneration, cerebrovascular diseases, 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 |
|---|---|---|
| OXSIGHT smart glassesAlso: There is noOXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss. | Device | OXSIGHT smart glasses |
Primary outcome
Changes from baseline CLVQOL scores at different time points
Time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
The Low vision Quality of Life Questionnaire (LVQOL) specifically investigates the QOL of visually impaired patients. The questionnaire consists of 25 closed items and examines four dimensions: distance vision, mobility and lighting; adjustment; reading and fine work; daily 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. CLVQOL is the Chinese version of LVQOL.
4 secondary outcomes
Changes from baseline visual acuity at different time points
Time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline contrast sensitivity at different time points
Time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline visual field at different time points
Time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Changes from baseline scores of mobility test at different time points
Time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 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 17 Jun 2020.
- Background: PubMed 11673287Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.
- Results publication: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
- The Number of People With Glaucoma Worldwide in 2010 and 2020Link provided by the sponsor.
- Glaucoma in China: How Big Is the Problem?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.
Questions about this trial
What is this clinical trial studying?
A study testing OXSIGHT smart glasses in people with Advanced Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 4 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 17 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiqing Li, doctor (13302235127, liyiqing@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline CLVQOL scores at different time points (time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.). 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 NCT04434612, which also lists 2 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 17 Jun 2020.