Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma

Advanced Glaucoma Clinical Trial

— OXSIGHT  

Official title:

Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04434612
• Other study ID #: zhongshanOCOXSIGHT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yiqing Li, doctor
• Phone: 13302235127
• Email: liyiqing[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

1. 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.

2. 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.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

1. age =10 years, able to complete all tests and inspections;

2. a definite diagnosis of primary or secondary glaucoma or glaucoma in children;

3. 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;

4. Visual acuity, intraocular pressure, and other eye conditions have been stable for more than 6 months.

Exclusion Criteria:

1. unable to cooperate with related inspections;

2. a history of eye surgery or eye laser within 6 months;

3. 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.;

4. pregnant or lactating women;

5. those who refuse to sign the informed consent or voluntarily withdraw from the study due to discomfort or other reasons.

Related Conditions & MeSH terms

• Advanced Glaucoma
• Glaucoma

Intervention

Device:
• OXSIGHT smart glasses
OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

References & Publications (2)

Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline visual acuity at different time points	ETDRS visual acuity chart was used.	The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Secondary	Changes from baseline contrast sensitivity at different time points	Pelli-Robson Contrast Sensitivity Charts were used.	The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Secondary	Changes from baseline visual field at different time points	Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.	The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
Secondary	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.	The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.

External Links

•   Glaucoma in China: How Big Is the Problem?
•   The Number of People With Glaucoma Worldwide in 2010 and 2020