Pilot Study on Improving Mobility and Universal Accessibility for Individuals With Visual Disabilities in Barcelona

NCT06602102 | Completed

• 2 other identifiers: BCNMob22S07345-001
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The project BCNMob informs about a research study approved by the Ethics Committee of the Hospital Universitario Mútua Terrassa The study aims to improve the Biel Glasses virtual reality glasses to assist patients with low vision in detecting and locating objects during mobility. Optometric evaluations and training sessions will be conducted, followed by tests in an urban environment in Barcelona. There are no significant risks associated with participation, although mild discomfort may arise. The information collected will be confidential and managed according to data protection legislation. No financial compensation will be offered.

Conditions

Low Vision Aids; Low Vision; Low Vision Blindness; Low Vision Digital Assistance

Keywords

low vision aids; low vision digital assistance

Outcome Measures

Primary Outcomes (2)

• Number of obstacles identified in time and avoided

  The number of obstacles present in the urban circuit that the participant detects and successfully avoids will be measured

  Throughout the testing session with the virtual reality glasses.

• Walking speed while using virtual reality (VR) glasses

  The walking speed of the participants will be measured while wearing virtual reality glasses in an urban environment.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (1)

• Number of obstacles touched

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Low Vision

Participants with Low Vision

Device: Mixed reality Glasses

Interventions

Mixed reality Glasses DEVICE

Mixed reality glasses are devices that combine elements of augmented reality and virtual reality. They allow users to overlay digital images onto the real world, enabling interaction with virtual objects in a physical environment. These glasses typically use sensors, cameras, and tracking technology to map the surroundings and provide an immersive experience. They are used in various applications, such as gaming, education, design, and professional training.

Low Vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for this research will consist of individuals who meet the inclusion and exclusion criteria, belonging to the metropolitan area of Barcelona.

You may qualify if:

• Minimum age of 18 years.
• Patients with peripheral vision (PV) \<20º in both eyes, and the patient expresses difficulty in their ability to move independently and safely in everyday environments.
• Distant visual acuity with the best possible correction in the better eye (VA) ≤ 0.3 (30%) and who expresses problems orienting in external environments.
• Patients with ophthalmological diagnoses: glaucoma, retinitis pigmentosa, Leber congenital amaurosis, high myopia, diabetic retinopathy, and other pathologies that cause hemianopsias.
• Ability to understand and follow the study instructions.
• Physical and cognitive ability to use virtual reality glasses and actively participate in the tests.
• Availability to participate in the study (8 hours on average spread over 3-4 sessions).
• The tests to evaluate the patien\';s visual examination will be conducted at the Centre Universitari de la Visió (CUV) CUV Terrassa: Passeig del Vint-i-dos de Juliol, 660, 08222 Terrassa.

You may not qualify if:

• Patients who are in active treatment for ocular conditions or who have received recent ophthalmological treatment or have had prior surgery within 3 months before the start of the study tests.
• Patients diagnosed with neurodegenerative diseases.
• Presence of medical or psychological conditions that may interfere with the safe participation in the study.
• Individuals who have difficulties moving independently due to a condition or pathology unrelated to their visual ability.

Sponsors & Collaborators

• Universitat Politècnica de Catalunya: lead

Study Sites (1)

Facultad de Óptica y Optometría de Terrassa

Terrassa, Barcelona, 08222, Spain

Location

Related Publications (1)

• Resnikoff S, Pascolini D, Etya'ale D, et al. Global data on visual impairment in the year 2002. Bull World Health Organ 2004; 82: 844-851. Peters D, Bengtsson B, Heijl A. Lifetime risk of blindness in open-angle glaucoma. Am J Ophthalmol 2013; 156: 724-730. Bourne RRA, Flaxman SR, Braithwaite T, et al. Magnitude, temporal trends, and projections of the global prevalence of blindness and distance and near vision impairment: a systematic review and meta-analysis. Lancet Glob Health 2017; 5: e888-e897. Bourne R, Price H, Taylor H, et al. New systematic review methodology for visual impairment and blindness for the 2010 Global Burden of Disease study. Ophthalmic Epidemiol 2013; 20: 33-39. Burton MJ, Ramke J, Marques AP, et al. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health 2021; 9: e489-e551. Wang MY, Rousseau J, Boisjoly H, et al. Activity limitation due to a fear of falling in older adults with eye disease. Invest Ophthalmol Vis Sci 2012; 53: 7967-7972. Kempen GIJM, Ballemans J, Ranchor AV, et al. The impact of low vision on activities of daily living, symptoms of depression, feelings of anxiety and social support in community-living older adults seeking vision rehabilitation services. Qual Life Res 2012; 21: 1405-1411. Wang MY, Rousseau J, Boisjoly H, et al. Activity limitation due to a fear of falling in older adults with eye disease. Invest Ophthalmol Vis Sci 2012; 53: 7967-7972. Ong SR, Crowston JG, Loprinzi PD, et al. Physical activity, visual impairment, and eye disease. Eye 2018; 32: 1296-1303. Steinberg EP, Tielsch JM, Schein OD, et al. The VF-14. An index of functional impairment in patients with cataract. Arch Ophth

  BACKGROUND

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Gispets, PhD

  Universidad Politécnica de Catalunya

  PRINCIPAL INVESTIGATOR

• Salut Alba-Arbalat, PhD

  Universidad Politécnica de Catalunya

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 22, 2024
• Primary Completion: November 12, 2024
• Study Completion: November 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)