Low Vision Digital AssistanceLIFE4LVNCT05184036
Development of an ICT Platform-Awareness System for the Support of Low Vision
An observational study of Low Vision Digital Assistance, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Vision Digital Assistance
- What is being tested?
- Low Vision
- How many people
- 500 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2018to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with LV according to WHO definition (10th edition, WHO International Statistical Classification of Diseases, Injuries and Causes of Death)
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki
Thessaloniki, Central Macedonia, 54636
About this study
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.
Read the 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
- Conditions
- Low Vision Digital Assistance
- Being tested
- Low Vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low VisionDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Sep 2018
- Primary completion5 Jan 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Vision Digital AssistanceStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Karampatakis, Aristotle University Of Thessaloniki
- Investigators
- Vasileios Karampatakis, Prof., Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184036
- Sponsor's protocol ID
- T1EDK-03742
- Acronym
- LIFE4LV
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36961662Gkioka 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.
PubMed 38440066Karampatakis 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.
PubMed 35638075Almaliotis 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.
PubMed 38333302Almpanidou 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.
PubMed 37048633Karampatakis 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.
PubMed 38330096Karampatakis 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.
PubMed 35399161
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an ICT Platform-Awareness System for the Support of Low Vision
- ClinicalTrials.gov ID
- NCT05184036
- Acronym / sponsor ID
- LIFE4LV / T1EDK-03742
- Conditions
- Low Vision Digital Assistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with LV according to WHO definition (10th edition, WHO International Statistical Classification of Diseases, Injuries and Causes of Death)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Vision* 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 | Diagnostic test | – |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 36961662Karampatakis 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.
- Results publication: PubMed 38440066Gkioka 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.
- Results publication: PubMed 35638075Karampatakis 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.
- Results publication: PubMed 38333302Almaliotis 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.
- Results publication: PubMed 37048633Almpanidou 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.
- Results publication: PubMed 38330096Karampatakis 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.
- Results publication: PubMed 35399161Karampatakis 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.
Related trials for Low Vision Digital Assistance
Recruiting
Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults
Visual Impairments, Low Vision Digital Assistance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Karampatakis, Prof. principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Vision Digital Assistance, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Design of a digital platform for the evaluation of basic parameters of visual function (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184036, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.