Evaluation of New Head-mounted Visual Aids Among Patients With Low Vision

NCT06076720 | Unknown DMC

• 1 other identifier: 2021KYPJ123
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa, RP, diabetic retinopathy (DR) are the most common blinding eye diseases in the world. Vision and visual field are often severely impaired, quality of life is reduced, and personal and family burdens are heavy. This kind of low vision people, can use visual AIDS and other instruments for visual rehabilitation training, maximize the function of residual vision, improve the quality of life. Beyes, HOLA, Acesight and OXSIGHT are among the latest eyeglasses devices that are expected to improve the quality of life for people with low vision. This research group intends to recruit advanced patients with primary glaucoma, AMD, RP, DR and other common blinding eye diseases who visited Zhongshan Ophthalmology Center of Sun Yat-sen University from June 2021 to December 2022 to study the changes of visual function and quality of life after wearing this new type of head-worn visual aids, and analyze relevant factors combined with clinical data. To evaluate the effect and influencing factors of the new head-mounted visual AIDS on patients, and provide theoretical basis for subsequent clinical research.

Conditions

Glaucoma; Age-related Macular Degeneration; Retinitis Pigmentosa; Diabetic Retinopathy

Keywords

Visual rehabilitation of low vision, head-mounted devices

Outcome Measures

Primary Outcomes (3)

• Comparison of changes in the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) scores at different time points

  The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.

  8 weeks after intervention

• Comparison of changes in the National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) scores at different time points

  The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.

  8 weeks after intervention

• Comparison of changes in the Low Vision Quality-of-Life Questionnaire (LVQOL) scores at different time points

  The Low Vision Quality-of-Life Questionnaire (LVQOL) specifically examines the QOL of patients with visual disability. The LVQOL is of the latter type, with the 25 items producing a summed score between 0 and 125 (the higher the score, the higher the quality of life). The 25 items are grouped into 4 subscales: distance vision, mobility and lighting; adjustment; reading and fine work; and daily life 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. The LVQOL was tested at baseline and 1 day, 1 week, 4 weeks, and 8 weeks after intervention.

  8 weeks after intervention

Secondary Outcomes (6)

• Comparison of changes in visual acuity at different time points

  8 weeks after intervention

• Comparison of changes in contrast sensitivity at different time points

  8 weeks after intervention

• Comparison of changes in kinetic visual field at different time points

  8 weeks after intervention

• Comparison of changes in functional magnetic resonance imaging (MRI) at different time points

  6 months after intervention

• Comparison of changes in mobility test at different time points

  8 weeks after intervention

Study Arms (1)

New head-mounted visual aids

EXPERIMENTAL

Wearing different head-mounted visual aids

Device: New head-mounted visual aids

Interventions

New head-mounted visual aids DEVICE

New head-mounted visual aids such as Beyes, HOLA, Acesight and OXSIGHT are the latest wearable electronic visual aids

New head-mounted visual aids

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥10 years, able to complete all tests and inspections
• a definite diagnosis of low vision or blindness:
• Criteria for low vision: the best corrected visual acuity of the better eye ≤0.3, and ≥0.05 or the visual field of the better eye no greater than 20° in radius around central fixation
• Criteria for blindness: the best corrected visual acuity of the better eye \<0.05 or the visual field of the better eye no greater than 10° in radius around central fixation
• 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 six months
• serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available.

  PMID: 29108747 RESULT

Related Links

• Vision Rehabilitation Preferred Practice Pattern®

MeSH Terms

Conditions

Glaucoma; Macular Degeneration; Retinitis Pigmentosa; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Degeneration; Retinal Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Yehong Zhuo

CONTACT

13352828998; zhuoyh@mail.sysu.edu.cn

Haishun Huang

CONTACT

13229518626; huanghsh9@mail2.sysu.edu.cn

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: September 24, 2023
• First Posted: October 11, 2023
• Study Start: October 10, 2023
• Primary Completion: August 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)