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

NCT05184036 | Active Not Recruiting

• 1 other identifier: T1EDK-03742
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision Digital Assistance

Outcome Measures

Primary Outcomes (3)

• Design of a digital platform for the evaluation of basic parameters of visual function

  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

  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

  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

Interventions

Low Vision DIAGNOSTIC_TEST

* The application of a questionnaire evaluating the functionality and quality of life and records several of the daily life of Greek LV patients. * The evaluation of the basic parameters of visual function included in the LIFE4LV platform in order to evaluate the effectiveness of this platform in correlation with the routine ophthalmologic exams. * The evaluation of existing digital supportive tools for LV and record of the patient's feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, 54636, Greece

Location

Related Publications (7)

• 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.

  PMID: 36961662 RESULT

• 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.

  PMID: 38440066 RESULT

• 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.

  PMID: 35638075 RESULT

• 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.

  PMID: 38333302 RESULT

• 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.

  PMID: 37048633 RESULT

• 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.

  PMID: 38330096 RESULT

• 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.

  PMID: 35399161 RESULT

Study Officials

• Vasileios Karampatakis, Prof.

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: September 1, 2018
• Primary Completion: January 5, 2023
• Study Completion: June 30, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

GR (1)