Development of an ICT Platform-Awareness System for the Support of Low Vision (LIFE4LV)

August 13, 2024 updated by: Vasileios Karampatakis, Aristotle University Of Thessaloniki
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Central Macedonia
      • Thessaloníki, Central Macedonia, Greece, 54636
        • Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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)

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Design of a digital platform for the evaluation of basic parameters of visual function
Time Frame: Baseline
The efficacy of a new digital color test will be evaluated in terms of its validity properties in identifying acquired color vision defects. Other basic parameters of the visual ability will also be included in the digital, LIFE4LV platform and be evaluated for their efficacy to serve as a useful tool both for LV patients and their physicians.
Baseline
The evaluation of the usability of a set of supportive digital applications
Time Frame: Baseline

The evaluation of the usability of supportive digital applications (magnification, text reading etc)

The expected outcomes would be:

  • Feedback from participants regarding the usability of supportive applications for LV
  • Better communication and interaction between LV individuals and their physician
  • Relief and less burden on their familiars
  • Better level of independence
  • Enhanced opportunity to engage in social and other activities
  • Improvement of their mental state to the extent that this can be achieved
Baseline
Design and Validation of the LIFE4LV questionnaire for the Greek population
Time Frame: Baseline
A new questionnaire will be developed and evaluated for its phychometric properties for the assessment of the functionality and QoL of LV patients in Greece
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Vasileios Karampatakis, Prof., Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

January 5, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 8, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1EDK-03742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Vision Digital Assistance

Clinical Trials on Low Vision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe