Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma (OXSIGHT)
Primary Purpose
Advanced Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OXSIGHT smart glasses
Sponsored by

About this trial
This is an interventional treatment trial for Advanced Glaucoma focused on measuring OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OXSIGHT smart glasses
Arm Description
Wearing OXSIGHT smart glasses
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes from baseline visual acuity at different time points
ETDRS visual acuity chart was used.
Changes from baseline contrast sensitivity at different time points
Pelli-Robson Contrast Sensitivity Charts were used.
Changes from baseline visual field at different time points
Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
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.
Full Information
NCT ID
NCT04434612
First Posted
June 10, 2020
Last Updated
June 15, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04434612
Brief Title
Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
Acronym
OXSIGHT
Official Title
Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Glaucoma
Keywords
OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OXSIGHT smart glasses
Arm Type
Experimental
Arm Description
Wearing OXSIGHT smart glasses
Intervention Type
Device
Intervention Name(s)
OXSIGHT smart glasses
Other Intervention Name(s)
There is no
Intervention Description
OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
Primary Outcome Measure Information:
Title
Changes from baseline CLVQOL scores at different time points
Description
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.
Time Frame
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Secondary Outcome Measure Information:
Title
Changes from baseline visual acuity at different time points
Description
ETDRS visual acuity chart was used.
Time Frame
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Title
Changes from baseline contrast sensitivity at different time points
Description
Pelli-Robson Contrast Sensitivity Charts were used.
Time Frame
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Title
Changes from baseline visual field at different time points
Description
Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
Time Frame
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Title
Changes from baseline scores of mobility test at different time points
Description
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.
Time Frame
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiqing Li, doctor
Phone
13302235127
Email
liyiqing@gzzoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhidong Li, doctor
Phone
15521059530
Email
aiyou1989@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11673287
Citation
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.
Results Reference
background
PubMed Identifier
16488940
Citation
Quigley 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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/16488940/?from_term=The+number+of+people+with+glaucoma+worldwide+in+2010+and+2020%5B
Description
The Number of People With Glaucoma Worldwide in 2010 and 2020
URL
https://pubmed.ncbi.nlm.nih.gov/11673287/?from_single_result=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C&expanded_search_query=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C
Description
Glaucoma in China: How Big Is the Problem?
Learn more about this trial
Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
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