Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
OXSIGHT
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2020
CompletedFirst Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 17, 2020
June 1, 2020
1.6 years
June 10, 2020
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Study Arms (1)
OXSIGHT smart glasses
EXPERIMENTALWearing OXSIGHT smart glasses
Interventions
OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 11673287BACKGROUNDQuigley 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.
PMID: 16488940RESULT
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 17, 2020
Study Start
June 6, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
June 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share