Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma

NCT ID: NCT04434612

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Advanced Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OXSIGHT smart glasses

Wearing OXSIGHT smart glasses

Group Type EXPERIMENTAL

OXSIGHT smart glasses

Intervention Type DEVICE

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

Interventions

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OXSIGHT smart glasses

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

Intervention Type DEVICE

Other Intervention Names

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There is no

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yiqing Li, doctor

Role: CONTACT

13302235127

Zhidong Li, doctor

Role: CONTACT

15521059530

References

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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.

Reference Type BACKGROUND
PMID: 11673287 (View on PubMed)

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.

Reference Type RESULT
PMID: 16488940 (View on PubMed)

Other Identifiers

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zhongshanOCOXSIGHT

Identifier Type: -

Identifier Source: org_study_id

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