An interventional study of Digital Blink Reminder Software (BlinkEasy) and Visual Hygiene Education (20-20-20 Rule). in Dry Eye Syndromes and Meibomian Gland Dysfunction (Disorder), sponsored by Asociación para Evitar la Ceguera en México. Not yet recruiting. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Asociación para Evitar la Ceguera en México · Not applicable, Interventional, and Prevention
This randomized clinical trial aims to evaluate if a blink reminder program ('BlinkEasy') reduces the progression of Meibomian gland loss in intensive digital screen users over three months , using infrared meibography as the primary structural measure. Additionally, the study will analyze changes in dry eye symptoms using the 12-item Ocular Surface Disease Index (OSDI) questionnaire and non-invasive tear break-up time (NIBUT).
The Ocular Surface Disease (OSD) in digital display terminal (VDT) users is considered a "lifestyle epidemic" affecting productivity and quality of life. High visual demand imposed by screens leads to a significant reduction in blink frequency and an increase in incomplete blinks. This blinking ineffectiveness results in tear film instability, reflected in a non-invasive tear break-up time (NIBUT) of \<10 seconds , and is strongly correlated with Meibomian Gland Dysfunction (MGD), which determines the severity of dry eye in these users.
While standard preventive measures like the "20-20-20 rule" are commonly recommended, evidence regarding their impact on objective morphological parameters of the ocular surface is limited or inconsistent. This study addresses the critical gap in long-term randomized clinical trials (RCTs) evaluating the sustainability of digital behavioral modifications on glandular morphology.
This is a randomized, parallel-group (1:1), open-label clinical trial. Participants will be intensive digital screen users (defined as ≥4 hours per day for at least 3 days a week) aged 18 to 40 years, recruited from the Hospital de la Ceguera (APEC).
Intervention Groups:
Experimental Group: Participants will install the "BlinkEasy" software on their digital devices. The program will display a visual alert approximately 8 times per minute designed to induce complete blinks; participants are instructed to blink twice with each alert. Adherence will be recorded via automated system logs.
Control Group: Participants will receive standard visual hygiene education, including the 20-20-20 rule and basic recommendations on blinking and visual rest.
The primary objective is to evaluate whether active blink reminders reduce the progression of Meibomian gland loss over a 12-week period using infrared meibography (Keratograph 5M) as the primary structural measure. The study hypothesizes that the intervention will reduce the progression of Meibomian gland loss by at least 10-15% of the total glandular area (or ≥0.5 points in meiboscore) compared to the control group. Secondary outcomes include changes in dry eye symptoms (measured by the 12-item OSDI questionnaire) and functional tear film parameters (NIBUT)
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 28 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Users assigned to this arm will use the 'BlinkEasy' software for 12 weeks.
Behavioral: Digital Blink Reminder Software (BlinkEasy)
Users in this arm will follow the 20-20-20 visual hygiene rule for 12 weeks.
Behavioral: Visual Hygiene Education (20-20-20 Rule).
Participants will install the 'BlinkEasy' software on their primary digital display terminal (VDT). The application provides automated visual notifications at a frequency of approximately 8 reminders per minute, specifically designed to prompt full, voluntary blinks. Participants are instructed to perform two consecutive complete blinks upon each visual cue. The software operates during the user's active screen time throughout the 12-week study period. System logs will be recorded to monitor daily adherence and software usage time to ensure consistency in the intervention delivery.
Also known as: Active Blink Reminder Program, Automated Blink Training Software, Computer-based Blink Alert System
Participants will receive a standardized educational session and written materials on visual hygiene and ergonomic practices for screen use. The primary intervention is the '20-20-20 rule,' which instructs the user to take a 20-second break every 20 minutes of screen use by looking at an object at least 20 feet (6 meters) away to facilitate ocular muscle relaxation and natural blinking. This group will not use any automated reminder software. Adherence will be self-reported by participants during follow-up visits over the 12-week study period.
Also known as: 20-20-20 Rule, Visual Hygiene Education, Standard Ergonomic Advice
Change from Baseline in Meibomian Gland Dropout Area and Meiboscore.
Quantitative and qualitative assessment of Meibomian gland loss using infrared meibography (Oculus Keratograph 5M). Glandular dropout will be measured as: Percentage of area loss: Calculated as the ratio of the area of lost glands to the total tarsal area (0-100%). Meiboscore (Jenvis Scale): A 4-point grading scale where 0 indicates no loss; 1 is ≤25% loss; 2 is 26-50% loss; 3 is 51-75% loss; and 4 is \>75% loss. Both eyes will be evaluated independently. Stabilization or reduction in these parameters in the experimental group compared to the control group will be considered a positive outcome.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.
Change from Baseline in Ocular Surface Disease Index (OSDI) Score.
Assessment of dry eye symptoms and their impact on vision-related quality of life using the validated 12-item OSDI questionnaire. The total score is calculated on a scale of 0 to 100, where: 0-12: Normal / No symptoms. 13-22: Mild dry eye. 23-32: Moderate dry eye. 33-100: Severe dry eye. Higher scores indicate greater symptom severity and functional limitation.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.
Change from Baseline in Non-Invasive Tear Break-Up Time (NIBUT).
Evaluation of tear film stability using the Oculus Keratograph 5M. The NIBUT measures the time (in seconds) between a complete blink and the first appearance of a dry spot or distortion in the reflected Placido disc image on the corneal surface. A longer NIBUT indicates better tear film stability. Measurements will be taken for each eye independently.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.
Change from Baseline in Mean Blink Rate (BPM).
The average number of blinks per minute (bpm) recorded by the software during active screen sessions. This objective measure will evaluate the improvement in blinking frequency compared to the control group.
Time frame: Weekly average throughout the 12-week study period.
Change from Baseline in Average Blink Duration.
The mean duration of individual blinks measured in milliseconds (ms). An increase in duration may correlate with more complete and effective blinks for ocular surface lubrication.
Time frame: Weekly average throughout the 12-week study period.
Reduction in Time Spent with Critical Blinking Deficiency.
Total time (minutes/seconds) per session where the participant's blink rate falls below the threshold of 7.5 blinks per minute. This variable measures the software's ability to prevent "staring" episodes.
Time frame: Weekly total throughout the 12-week study period.
Adherence to the Digital Intervention.
Total screen time (hours and minutes) with the software active and the total number of blink alerts triggered and acknowledged during the study.
Time frame: Total accumulated over 12 weeks.
No study locations are listed for this record.
Plan to share: No
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Asociación para Evitar la Ceguera en México