Clinical trial NCT05184036: Development of an ICT Platform-Awareness System for the Support of Low Vision
Official title: Development of an ICT Platform-Awareness System for the Support of Low Vision
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Vision Digital Assistance
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with LV according to WHO definition (10th edition, WHO International Statistical Classification of Diseases, Injuries and Causes of Death)

Brief summary: Low Vision (LV) has a detrimental impact on Quality of Life (QoL) of affected individual's and is considered a major healthcare problem according to World Health Organization. The primary objective of this study is the development of an integrated ICT platform-awareness system for the assistance of individuals with LV for the evaluation of visual ability. It is of high importance to develop and apply appropriate strategies aiming at the improvement of daily living and access to healthcare services of patients with LV. Secondary objectives are the evaluation of a suite of supportive mobile applications (magnification, reading, etc)'' for individuals with LV in order to improve their ability to perform daily activities and the development of a new questionnaire to assess the functionality and quality of life of individuals with LV.Investigators will conduct an effectiveness study to determine if the features of LIFE4LV platform provide low vision patients and their physicians with appropriate benefits.

Detailed description: Low Vision (LV) refers to a significant impairment of vision without the possibility of improvement by any therapeutic intervention, affecting significantly the abilities of LV individuals. In the 10th revision of the WHO International Statistical Classification of Diseases, Injuries and Causes of Death, 'low vision' is defined as visual acuity of less than 6/18 but equal to or better than 3/60, or a corresponding visual field loss to less than 20°, in the better eye with the best possible correction.

The aim of the current study is to explore innovative strategies to support individuals with LV using new digital technologies developed in the field of information and these applications to assist these patients.

The development of a patient digital file is an additional part of innovation since the possible changes during the course of the disease could be detected and recorded.

Specifically, the current study aims at the development of an integrated ICT platform-awareness system for the support of LV individuals, including a digital platform for the evaluation of visual ability of LV patients in concert with their physician.

Specifically, objectives of the study are:

* The development of the digital platform consisted of applications assessing basic parameters of the visual function. The platform aims to improve the level of patient's follow up and communication with their physician and does not replace the physical examination in any case.
* Additionally, the election of supportive mobile applications (magnification, reading, etc)'' for individuals with LV in a form of a supportive suite of digital tools may facilitate the performance of basic activities.
* Another objective is the design and validation of a new questionnaire to assess the functionality and the quality of life of Greek individuals with LV.
* The development of a training handbook/manual is also considered as an important parameter to provide patients with appropriate instructions for the correct use of the assistive digital tools and applications. The above manual aims to improve the utilization of the digital platform and the suite, as some parameters should be evaluated under the appropriate conditions and requires a period of education, especially when individuals are not familiar with digital media

Eligibility criteria: Inclusion Criteria

1. Visual acuity in the better-seeing eye 20/50-20/400
2. Visual field at least 10 degrees
3. Informed written consent to the processing of personal data

Exclusion Criteria:

1. Younger than 18 years of age
2. Severe mental disorder (any type of dementia, under medication that affects mental function, etc.) or neurological problems that cause difficulty in communication
3. End-stage diseases (chronic kidney disease, cancer, liver failure, etc.), which may affect their performance and their ability
4. Severe mobility problems
5. Active or rapidly progressive eye disease in an acute phase that can affect directly visual performance e.g. intravitreal hemorrhage
6. Ocular diseases causing reversible visual impairment (e.g. cataract, uncorrected refractive errors etc.)
7. Not receiving topical or systemic treatment with known toxic effects on the lens, retina or optic nerve (e.g. ethambutol, chloroquine or hydroxychloroquine, etc.)

Primary outcomes:
measure: Design of a digital platform for the evaluation of basic parameters of visual function
timeFrame: Baseline
measure: The evaluation of the usability of a set of supportive digital applications
timeFrame: Baseline
measure: Design and Validation of the LIFE4LV questionnaire for the Greek population
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
state: Central Macedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Vasileios Karampatakis, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karampatakis V, Almaliotis D, Talimtzi P, Almpanidou S. Design and Validation of a Novel Smartphone-Based Visual Acuity Test: The K-VA Test. Ophthalmol Ther. 2023 Jun;12(3):1657-1670. doi: 10.1007/s40123-023-00697-x. Epub 2023 Mar 24.
citation: Gkioka M, Almpanidou S, Lioti N, Almaliotis D, Karampatakis V. Daily Functionality of People with Low Vision: The Impact of Visual Acuity, Depression, and Life Orientation-A Cross-Sectional Study. Behav Neurol. 2024 Feb 26;2024:4366572. doi: 10.1155/2024/4366572. eCollection 2024.
citation: Karampatakis V, Almaliotis D, Papadopoulou EP, Almpanidou S. Design of a novel smartphone-based photostress recovery time test for detecting abnormalities in the macula. A cross-sectional study. Ann Med Surg (Lond). 2022 Apr 29;77:103699. doi: 10.1016/j.amsu.2022.103699. eCollection 2022 May.
citation: Almaliotis D, Almpanidou S, Chatzimbalis T, Nikolaidou A, Talimtzi P, Karampatakis V. Correlation between color vision, visual acuity, contrast sensitivity and photostress recovery in the visually impaired: a cross-sectional study. Ann Med Surg (Lond). 2023 Nov 20;86(2):742-747. doi: 10.1097/MS9.0000000000001522. eCollection 2024 Feb.
citation: Almpanidou S, Almaliotis D, Karamitopoulos L, Topouzis F, Konstas AG, Labiris G, Dardavesis T, Fountoulakis KN, Chatzisavvas KC, Karampatakis V. Development and Validation of the Life for Low Vision Questionnaire (LIFE4LVQ) Using Rasch Analysis: A Questionnaire Evaluating Ability and Independence. J Clin Med. 2023 Mar 28;12(7):2549. doi: 10.3390/jcm12072549.
citation: Karampatakis V, P Papadopoulou E, Almpanidou S, Karamitopoulos L, Almaliotis D. Evaluation of contrast sensitivity in visually impaired individuals using K-CS test. A novel smartphone-based contrast sensitivity test-Design and validation. PLoS One. 2024 Feb 8;19(2):e0288512. doi: 10.1371/journal.pone.0288512. eCollection 2024.
citation: Karampatakis V, Almaliotis D, Karamitopoulos L, Kalliris G, Almpanidou S. A Novel Smartphone-Based Color Test for Detection of Color Vision Defects in Age Related Macular Degeneration. J Ophthalmol. 2022 Mar 31;2022:9744065. doi: 10.1155/2022/9744065. eCollection 2022.