Testing a workplace program to prevent computer vision syndrome (CVS) and dry eye syndrome (DES) in computer users
| ISRCTN | ISRCTN10265538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10265538 |
| Hospital del Mar Clinical Research Ethics Committee Reference Number | 2025/12090/I |
| Protocol serial number | PI25/00032 |
| Sponsors | Universitat Pompeu Fabra, Hospital del Mar Research Institute |
| Funder | This study has received external grant funding from the Catalan Society of Occupational Health, through the Foundation of the Academy of Medical and Health Sciences of Catalonia and the Balearic Islands. In addition, the study has been partially supported through in-kind institutional contributions from the Hospital del Mar Research Institute and the University of Alicante. Both institutions have provided the facilities, equipment, instruments, and materials required to conduct the clinical and occupational assessments of study participants, as well as the resources necessary to evaluate and implement workplace adaptations as part of the intervention. |
- Submission date
- 16/05/2025
- Registration date
- 20/05/2025
- Last edited
- 28/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The INTERVIS study aims to prevent and reduce two common eye problems associated with prolonged screen use at work: Computer Vision Syndrome (CVS) and Dry Eye Syndrome (DES). These conditions can cause symptoms such as eye strain, dryness, blurred vision, and headaches, and are common among workers who regularly use computers and other screen-based devices. The study will evaluate whether a comprehensive workplace intervention can reduce the frequency of CVS and DES, improve workers’ visual and ocular health and quality of life, and provide good value for the resources required to implement it.
Who can participate?
The study will include 224 employees aged 18–70 years who use video display terminals (VDTs) for at least four hours per workday. Participants must work full time, have worked in the selected work unit for at least one year, be actively employed when the study begins, and provide written informed consent.
What does the study involve?
Work units, rather than individual participants, will be randomly assigned to either the intervention group or the control group. Participants in the control group will continue to receive usual occupational health care.
The intervention will combine several preventive measures, including:
assessment and improvement of workstation ergonomics, lighting, temperature, and humidity;
education on healthy lifestyle and visual habits, including physical activity, diet, appropriate use of dietary supplements, smoking cessation, regular screen breaks, and blinking;
optometric and ophthalmological screening to identify CVS, DES, and other visual or ocular problems at an early stage; and
individualized recommendations based on each participant’s screening results and risk profile, which may include optical correction, training in the 20-20-20 rule, blinking exercises, or lubricating eye drops when clinically appropriate.
No dietary supplements will be provided as part of the intervention; participants will receive evidence-based information about their potential role and appropriate use.
Participants will complete questionnaires and undergo visual and ocular assessments at the beginning of the study, after 6 months, and after 12 months. Quality of life and information on healthcare use and sickness absence will also be collected to assess the costs and benefits of the intervention.
What are the possible benefits and risks of participating?
Participants may benefit from early identification of visual or ocular problems and from recommendations aimed at improving visual comfort and workplace conditions. However, individual benefit cannot be guaranteed. The study procedures are considered low risk. Some participants may experience minor inconvenience or temporary discomfort during eye examinations or may find the questionnaires and study visits time-consuming.
Where is the study run from?
The study is being conducted at Hospital del Mar in Barcelona and the University of Alicante, Spain.
When is the study starting and how long is it expected to run for?
The overall study is expected to run for approximately three years. Each participant will be followed for 12 months, with assessments at baseline, 6 months, and 12 months.
Who is funding the study?
The study has received external grant funding from the Catalan Society of Occupational Health, through the Foundation of the Academy of Medical and Health Sciences of Catalonia and the Balearic Islands. In addition, the study is partially supported through in-kind institutional contributions from the Hospital del Mar Research Institute and the University of Alicante.
Who is the main contact?
Prof. Dr José María Ramada Rodilla
Email: jramada@hmar.cat
Contact information
Principal investigator
Hospital del Mar, Servicio de Salut Laboral
Passeig Marítim de la Barceloneta, 25-29
Barcelona
08003
Spain
 ORCID ID |
0000-0002-3854-1596 |
|---|---|
| Phone | +34 609480592 |
| jramada@hmar.cat |
Public
Hospital del Mar, Servicio de Salut Laboral
Passeig Marítim de la Barceloneta, 25-29
Barcelona
08003
Spain
| ORCID ID |
0009-0005-9742-2270 |
|---|---|
| Phone | +34 665272090 |
| joana.guerrero.monge@hmar.cat |
Scientific
Departamento de Óptica, Farmacología y Anatomía
Universidad de Alicante
Carretera San Vicente del Raspeig s/n
San Vicente del Raspeig - Alicante
03690
Spain
| ORCID ID |
0000-0003-0281-7949 |
|---|---|
| Phone | +34 619987300 |
| mm.segui@gcloud.ua.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter cluster randomized controlled trial with blinded data analysis |
| Secondary study design | Cluster randomised trial |
| Participant information sheet | 47356 PIS INFORMED CONSENT - INTERVIS.pdf |
| Scientific title | Cluster randomized controlled trial of a workplace intervention to prevent computer vision syndrome and dry eye syndrome in workers using video display terminals |
| Study acronym | Study INTERVIS |
| Study objectives | Current study objectives as of 28/08/2026: In accordance with the SPIRIT 2025 recommendations for the reporting of randomized trial protocols, the main prespecified objectives of the INTERVIS study are: 1. To evaluate the effectiveness of the INTERVIS multicomponent workplace intervention, compared with usual occupational health care, in reducing the prevalence of Computer Vision Syndrome (CVS) and Dry Eye Syndrome (DES) among workers exposed to video display terminals (VDTs), with CVS and DES prevalence at 12 months as the co-primary outcomes 2. To assess differences in the prevalence of CVS and DES between women and men and to evaluate whether sex modifies the effect of the intervention on these outcomes 3. To evaluate the implementation of the INTERVIS intervention through a comprehensive process evaluation assessing recruitment, context, reach, dose delivered, dose received, intervention fidelity, participant adherence, and participant satisfaction 4. To assess the cost-effectiveness and cost-utility of the INTERVIS intervention compared with usual occupational health care over the 12-month study period, from both the National Health System and societal perspectives, using incremental cost per case of CVS and DES prevented and incremental cost per quality-adjusted life year (QALY) gained _____ Previous study objectives: Hypothesis 1 (H1): Significant sex-based differences exist in the prevalence of Computer Vision Syndrome (CVS) and Dry Eye Syndrome (DES) among visual display terminal (VDT) users, both in intervention and control groups. Hypothesis 2 (H2): A multicomponent, evidence-based workplace intervention will lead to a significant reduction in the prevalence of CVS and DES among VDT users, regardless of sex. This intervention will include: a) Comprehensive training in healthy lifestyle behaviors (physical activity, nutritional supplementation, smoking cessation) and education on modifiable visual health risk factors associated with prolonged screen exposure (behavioral, hygienic, postural, and environmental guidelines) — health promotion, primary prevention; b) Ergonomic optimization of fixed workstations (adjustments in viewing distance, screen tilt, ambient temperature, lighting, and glare) — primary prevention; c) Visual health surveillance, including refraction assessment, tear film and ocular surface testing, and administration of validated symptom questionnaires — secondary prevention; and d) Visual health counseling, incorporating guidance on corrective lenses, blinking exercises, scheduled visual breaks following the 20/20/20 rule, and the use of lubricating eye drops — tertiary prevention. We anticipate that this integrated intervention will reduce the prevalence of CVS and DES by an estimated 65–75% in both male and female participants. Hypothesis 3 (H3): The proposed intervention will be cost-effective, delivering a favorable cost-benefit ratio for participating organizations through improved worker well-being, reduced absenteeism, and enhanced productivity. |
| Ethics approval(s) |
Approved 26/11/2025, Hospital del Mar Clinical Research Ethics Committee (c/Doctor Aiguader, 88 (Edifici PRBB). 1ª planta, espai 163.05, Barcelona, 08003, Spain; +34 93 316 06 79 / +34 93 316 06 77; ceic-psmar@imim.es), ref: 2025/12090/I |
| Health condition(s) or problem(s) studied | Prevention of computer vision syndrome and dry eye syndrome in workers using video display terminals |
| Intervention | Current interventions as of 28/08/2026: Stratified cluster randomization by study site will be performed to allocate clusters to either the intervention or usual-care control group. Participants in both groups will continue to receive standard occupational health care provided by the Occupational Health Service (OHS). In the intervention clusters, participants will additionally receive the INTERVIS multicomponent intervention over a 12-month period, comprising primary prevention, secondary prevention, and tertiary prevention with individualized risk-based management. All intervention components will take into account relevant sex-related anatomical and physiological differences. Primary prevention actions Primary prevention will encompass both the control of occupational risk factors and health promotion strategies. A comprehensive ergonomic assessment will be conducted at each workstation, taking into account individual worker characteristics, usual computer-working posture, and environmental conditions. Eye-to-screen distance and cervical posture will be assessed. Two standardized photographs will be obtained for each seated participant: one in the sagittal plane and one perpendicular to the screen. The eye-screen angle (α), viewing angle (α′), and screen tilt angle (β) will be calculated using QCAD Trial version 3.19.2. Environmental conditions will be assessed by measuring dry temperature and relative humidity using a PCE-WB 20SD thermo-hygrometer and illumination levels at three positions within the workstation using an ISO-TECH ILM 1337 luxmeter. Glare, screen reflections, task lighting, and air-conditioning performance will also be evaluated. When workstation or environmental conditions are identified as suboptimal, appropriate technical modifications will be implemented in accordance with Spanish Royal Decrees 486/1997 and 488/1997, EU Directive 90/270/EEC, guidance from the Spanish National Institute for Safety and Health at Work (INSST), and ISO 11226:2000. These adaptations may include adjustments to viewing distance, screen tilt and height, lighting intensity, and relative humidity. Health promotion activities will comprise comprehensive training in healthy lifestyle behaviors and targeted education on visual ergonomics and ocular health during VDT use. Healthy lifestyle education will address outdoor physical activity, a healthy diet rich in vegetables, fish, antioxidants, omega-3 fatty acids, and carotenoids, evidence-based information on the potential role and appropriate use of dietary supplements for visual and ocular health, and support for smoking cessation. No dietary supplements will be provided as part of the intervention. Education on visual ergonomics and ocular health will emphasize regular breaks during VDT use, complete and frequent blinking, ergonomic workstation design, and optimization of lighting, temperature, and humidity. These activities will be delivered through synchronous online training sessions and structured in-person workshops. Secondary prevention actions A tailored screening program will be implemented for the early identification of Computer Vision Syndrome (CVS), Dry Eye Syndrome (DES), refractive problems, and ocular surface or tear-film abnormalities. Assessments will be conducted at baseline (T0), 6 months (T1), and 12 months (T2). Examinations will be performed by qualified visual health professionals, including ophthalmologists, optometrists, occupational physicians, and preventive medicine specialists. In addition to routine visual examinations included in occupational health surveillance for workers exposed to video display terminals (VDTs), assessments will include objective and subjective refraction, examination of ocular surface structures (eyelids, conjunctiva, and cornea), and evaluation of tear-film quantity and quality. Visual symptoms will be assessed using two validated self-administered questionnaires: the Computer Vision Syndrome Questionnaire (CVS-Q©) for CVS and the Ocular Surface Disease Index (OSDI©) for DES. Based on screening findings and relevant individual and occupational factors, including comorbidities, current treatments, optical correction status, and VDT exposure patterns, participants will be stratified into three mutually exclusive risk categories. Participants with no ocular surface or tear-film abnormalities, no relevant comorbidities or ongoing treatments, questionnaire scores below the established cut-off values, no uncorrected refractive error, and adequate VDT exposure, defined as no more than eight hours per day with regular breaks, will be classified as low risk. Participants with an uncorrected refractive error and/or potentially unfavorable VDT exposure patterns, defined as more than eight hours of VDT use per day and/or insufficient or irregular breaks, but without ocular surface or tear-film abnormalities, relevant comorbidities or ongoing treatments, or questionnaire scores exceeding the established cut-off values, will be classified as medium risk. Participants presenting at least one ocular surface or tear-film abnormality, a relevant comorbidity or ongoing treatment, or questionnaire scores exceeding the established cut-off values will be classified as high risk, irrespective of refractive status, VDT exposure duration, or break patterns. Tertiary prevention and individualized risk-based management Interventions will be tailored according to the risk stratification and findings obtained during screening. Participants for whom optical correction is clinically indicated will receive appropriate refractive management. Participants with modifiable VDT-related behavioral risk factors will receive structured training on the 20-20-20 rule (every 20 minutes, focusing on an object at least 20 feet away for a minimum of 20 seconds), supported by the freely available Eyecare 20-20-20 application. Participants with ocular surface or tear-film abnormalities, relevant symptoms, or other clinical indications will additionally receive prescribed blinking exercises and/or lubricating ophthalmic drops, as appropriate. These individualized measures will complement the primary and secondary prevention components and provide risk-based management according to each participant’s clinical and occupational profile. Usual occupational health care Throughout the 12-month study period, OHS at each participating site will continue to provide standard occupational health care to participants in both intervention and control clusters. This will include occupational risk assessment, investigation and management of work-related injuries, health surveillance, smoking cessation programs, structured training, occupational health information, and return-to-work support where appropriate. Evaluation of the intervention 1) Visual and ocular health outcomes The co-primary outcomes will be the prevalence of CVS and DES at 12 months. Outcomes will also be assessed at baseline (T0) and 6 months (T1). CVS will be defined as a CVS-Q© score of 6 or higher. DES will be defined as an OSDI© score of 13 or higher in combination with at least one abnormal ocular surface and/or tear-film test result. 2) Process evaluation The process evaluation will assess recruitment, context, reach, dose delivered, dose received, intervention fidelity, participant adherence, and participant satisfaction. Recruitment will describe the strategies and procedures used to approach, attract, and enroll eligible workers. Reach will describe the extent to which enrolled participants are exposed to the intervention and its individual components. Dose delivered and dose received will assess the amount of intervention provided and participant engagement, respectively. Intervention fidelity will assess consistency with the planned intervention, while participant adherence will reflect attendance relative to the intervention dose delivered. Satisfaction will assess participants’ perceptions of the intervention. Data will be collected using structured questionnaires, researcher-maintained records, and focus groups. Qualitative data obtained from focus groups will be analyzed using thematic analysis. 3) Cost-effectiveness and cost-utility evaluation Cost-effectiveness and cost-utility analyses will be conducted from both the National Health System and societal perspectives over a 12-month time horizon. All costs will be expressed in 2026 euros (€). Costs will include healthcare resource utilization, intervention implementation costs, and resources required to implement workplace adaptations. From the societal perspective, productivity losses will be considered as indirect costs and estimated using the human capital approach based on sick leave data reported by participants. Effectiveness will be assessed separately for CVS and DES. Health utilities will be derived from the EQ-5D-3L using the Spanish value set, with measurements obtained at baseline (T0), 6 months (T1), and 12 months (T2). Quality-adjusted life years (QALYs) will be calculated using the area-under-the-curve method. Separate incremental cost-effectiveness ratios will be estimated for CVS and DES, expressed as the incremental cost per case of CVS prevented and the incremental cost per case of DES prevented, respectively. Cost-utility will be expressed as the incremental cost per QALY gained. _____ Previous interventions: Stratified randomization by center will be performed to assign clusters to the intervention or control group. In the control group clusters, only the standard routine activities carried out by the Occupational Health Service (OHS) will be implemented. In the intervention group clusters, in addition to these usual activities, actions will be undertaken across the three levels of prevention (primary, secondary, and tertiary), along with a health promotion component. In all cases, physical, anatomical, and physiological differences between men and women will be considered. * Primary prevention actions: - An ergonomic assessment of the workstation will be conducted, taking into account individual worker characteristics, habitual computer posture, and environmental conditions. - Measurements will include the eye-to-screen distance and neck posture, assessed via direct observation. Two photographs will be taken: one from the sagittal plane while the participant is seated, and another from a perpendicular angle to the screen. Using Qcad Trial software version 3.19.2, the following angles will be calculated: the eye-to-screen angle (α), the viewing angle (α′), and the screen tilt angle relative to the horizontal (β). - Environmental conditions will also be evaluated. Dry temperature and relative humidity will be measured using a thermohygrometer (PCE-WB 20SD), and illuminance will be assessed using a luxmeter (ISO-TECH ILM 1337) at three different points within the workstation, with the average recorded. Additional assessments will include glare, screen reflections, localized lighting, and air conditioning status. - Ergonomic and environmental adjustments will be made based on the standards set out in the Spanish Royal Decree 486/1997, Directive 90/270/EEC, the INSST guide (2021), and ISO 11226:2000. When workstation setup is suboptimal, distances, angles, and heights will be modified. If ambient conditions (temperature, humidity, lighting, air velocity) are inadequate, technical adjustments will be made, such as regulating air conditioning, providing humidifiers, or adjusting lighting power. * Secondary prevention actions: - At the Optometry Clinic, initial screening (T0) will be conducted to detect CVS and/or DES, with follow-up assessments at 6 months (T1) and 12 months (T2). - A multidisciplinary team of visual health professionals (ophthalmologists, optometrists, occupational physicians, and preventive medicine specialists) will perform comprehensive ocular and visual examinations. - In addition to the standard vision checks included in occupational health surveillance for workers exposed to video display terminals (VDT), the examination will include objective and subjective refraction, ocular surface assessment (eyelids, conjunctiva, cornea), and tear film evaluation (production and quality). - Two validated self-administered questionnaires will be used to evaluate CVS and DES symptoms: the Computer Vision Syndrome Questionnaire (CVS-Q©) (Seguí-Crespo et al., 2015) and the Ocular Surface Disease Index (OSDI©) (Schiffman et al., 2000), respectively. Based on the screening results and additional factors (comorbidities, ongoing treatments, optical correction, VDT exposure patterns such as duration and rest breaks), participants will be categorized into three risk levels: - Low risk: Workers with no screening abnormalities, no comorbidities or treatments, and adequate VDT exposure (≤8 hours/day with regular breaks), even if uncorrected refractive errors are present. - Moderate risk: Workers meeting low-risk criteria but not taking regular breaks. - High risk: Workers meeting moderate-risk criteria but showing ocular surface or tear film alterations, with comorbidities, treatments, or exceeding the questionnaire thresholds. * Tertiary prevention actions: Based on risk classification, the following measures will be implemented: - Low risk: Guidance on optical correction if required. - Moderate risk: Optical correction guidance plus training on the 20-20-20 Rule using the free mobile application Eyecare 20 20 20. - High risk: All measures for moderate-risk individuals, plus prescription of blinking exercises and/or recommendation of lubricating eye drops. * Health promotion actions: The program includes several components aimed at providing comprehensive training on: - Healthy lifestyle habits (physical activity, dietary supplementation, smoking cessation), - and visual health factors associated with DES use (behavioral, hygienic, postural, and environmental recommendations). These components are complementary and essential to enhancing workers’ health and overall well-being. Evaluation of the Intervention 1) Assessment of impact on visual health: The prevalence of CVS and DES will be measured using validated questionnaires and clinical tests described previously, both before the intervention (T0) and at two follow-up points (T1 and T2). 2) Process evaluation: Following widely used frameworks in the literature (Linnan & Steckler, 2002; Wierenga et al., 2012), the process evaluation will consider key indicators, including: - Recruitment (methods used to engage participants in the program), - Context (social and workplace factors that may influence implementation), - Reach (number, proportion, and characteristics of participants), - Dose delivered (quantity and nature of intervention components administered), - Fidelity (quality and consistency of intervention implementation), - Satisfaction (participants' perceptions of the intervention upon its completion). Data for this component will be collected using qualitative methods (focus groups and/or semi-structured interviews) and a tailored ad hoc questionnaire. 3) Cost-effectiveness and cost-utility evaluation: Cost data will include: - Implementation costs, documented by research staff records; - Healthcare resource utilization associated with screen exposure (primary care, optometry, ophthalmology, and pharmacy); - Other resources (e.g., humidifiers, lighting regulators, desk lamps); - Productivity losses, including temporary disability, absenteeism, and presenteeism. Effectiveness will be assessed using the CVS-Q© and OSDI© questionnaires. Health utility will be estimated using the EQ-5D-5L health-related quality of life questionnaire, administered at T0 and T2. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Current primary outcome(s) as of 28/08/2026: |
| Key secondary outcome measure(s) |
Current key secondary outcome(s) as of 28/08/2026: |
| Completion date | 31/03/2029 |
Eligibility
| Participant type(s) | Employee, Health professional, Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Current key inclusion criteria as of 28/08/2026: Selected clusters will consist of independent work units, defined as either a standalone building or a clearly delineated work area located on a separate floor within the same building. Eligible participants must be aged 18–70 years, hold a full-time employment contract, have worked in the selected cluster for at least one year, be actively employed at study initiation, and have occupational exposure to video display terminals (VDTs) for at least four hours per workday. _____ Previous key inclusion criteria: Participants must have been working in the selected cluster (independent building) for at least the last year, hold a full-time contract, and be actively employed at the beginning of the study. |
| Key exclusion criteria | Current key exclusion criteria as of 28/08/2026: 1. History of ocular surgery or ocular procedures that may substantially affect the ocular surface, tear film, or visual function 2. Presence of active ocular disease, other than CVS or DES, that may interfere with the assessment of visual or ocular outcomes 3. Presence of systemic diseases known to substantially affect the ocular surface or tear production, including autoimmune or connective tissue diseases such as Sjögren’s syndrome 4. Current use of systemic or topical medications known to substantially affect tear production, tear-film stability, or ocular surface status 5. Any other ophthalmological, systemic, or neurological condition that, in the investigators’ clinical judgment, could substantially interfere with the assessment of CVS or DES or act as a major confounding factor 6. Inability to complete the study questionnaires or undergo the scheduled optometric and ophthalmological examinations 7. Failure to provide written informed consent _____ Previous key exclusion criteria: 1. Workers under 18 or over 70 years old 2. Workers not currently employed in the selected cluster (independent building) for at least the past year 3. Workers with part-time contracts 4. Individuals who, although belonging to any of the intervention or control clusters, are not actively employed at the beginning of the study 5. Individuals who do not consent to sign the informed consent document |
| Date of first enrolment | 01/10/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Barcelona
08003
Spain
San Vicente del Raspeig, Alicante.
03690
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated and/or analyzed during the study will be stored in non-publicly available secure repositories and will be available upon reasonable request. Requests for access to the study data should be addressed either to the corresponding author, Begoña Domenech-Amigot (b.domenech@ua.es), or to the first author José María Ramada Rodilla (jramada@hmar.cat). As a multicenter study with shared objectives and methodology, and requiring joint analysis of the data collected at the two participating institutions (Hospital del Mar [HMar] and the University of Alicante [UA]), the ownership of the aggregated data will be shared by the researchers from both centers. Data collected during the different phases of the intervention will be stored in dedicated databases: data from HMar will be stored in a secure repository at Universitat Pompeu Fabra (UPF), while data from UA will be stored in a secure repository at the University of Alicante. Aggregated data from both centers will be archived in the repositories of both universities. At HMar, the project will be supported by the Information Technology Services (SIT) of the Department of Medicine and Life Sciences (MELIS) at UPF, which has extensive experience in managing and protecting sensitive data. SIT will manage the databases using a SQL system and will oversee the handling of initial and follow-up questionnaire data collected through online survey platforms such as QuestionPro, Qualtrics, or similar tools. At UA, the project will be supported by the University’s Information Services (SI), which will provide technical and logistical support for data storage, drawing on its experience in the secure management of sensitive research data. The SI will be responsible for the administration of data from questionnaires and visual assessments, both at baseline and during follow-up, also collected via platforms such as QuestionPro, Qualtrics, or similar. Additionally, UA has a dedicated Data Protection Office that will supervise the research-related processing of data to ensure compliance with applicable regulations. The data collected in this study will be classified into two categories. A minimal portion will consist of personal information, limited to participants’ contact details (phone number and/or email), which will be encrypted to ensure security. All other data will be pseudonymized using randomly generated identifiers, making direct identification of individuals impossible. Access to personal data will be restricted to the research team, while non-personal data, once processed for analysis, may be made available upon reasonable request in accordance with FAIR principles—ensuring that data and metadata are findable, accessible, interoperable, and reusable. All data processing will comply with the provisions of the General Data Protection Regulation (EU Regulation 2016/679) and the Spanish Organic Law 3/2018. Written informed consent will be obtained from all participants prior to any data collection. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/05/2025 | No | Yes |
Additional files
- 47356 PIS INFORMED CONSENT - INTERVIS.pdf
- Participant information sheet
Editorial Notes
28/08/2026: The following changes were made to the study record:
1. The public title was changed from "Testing a workplace program to prevent computer vision syndrome and dry eye syndrome in computer users" to "Testing a workplace program to prevent computer vision syndrome (CVS) and dry eye syndrome (DES) in computer users".
2. The study objectives were changed.
3. The interventions were changed.
4. The primary outcome(s) were changed.
5. The key secondary outcome(s) were changed.
6. The key inclusion criteria were changed.
7. The key exclusion criteria were changed.
8. The Date of first enrolment was changed from 20/07/2026 to 01/10/2026.
9. The Date of final enrolment was changed from 30/10/2026 to 31/12/2026.
10. The plain English summary was updated to reflect these changes.
11. A sponsor was added.
12. The funder was changed from Instituto de Salud Carlos III.
21/07/2026: The date of first enrolment was changed from 15/06/2026 to 20/07/2026.
16/04/2026: The date of first enrolment was changed from 01/04/2026 to 15/06/2026.
20/01/2026: The following changes were made to the study record:
1. Ethics approval details added.
2. The date of first enrolment was changed from 01/01/2026 to 01/04/2026.
3. The date of final enrolment was changed from 30/06/2026 to 30/10/2026.
4. The completion date was changed from 31/12/2028 to 31/03/2029.
16/05/2025: Trial's existence confirmed by Instituto de Salud Carlos III.
