Dry Eye Syndromes, Meibomian Gland Dysfunction (Disorder)
Conditions
Keywords
Dry eye, Blinking, Meibography, Digital Displays, Meibomian Gland Atrophy, BlinkEasy
Brief summary
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).
Detailed description
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)
Interventions
BEHAVIORALDigital Blink Reminder Software (BlinkEasy)
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.
BEHAVIORALVisual Hygiene Education (20-20-20 Rule).
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.
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The trial is open-label because the nature of the behavioral intervention (installation of the 'BlinkEasy' software) does not allow for the masking of participants or the personnel delivering the training. To maintain the integrity of the objective results, all clinical measurements-including meibography for Meiboscore and NIBUT-will be performed following strictly standardized protocols.
Intervention model description
A randomized, parallel-group, open-label clinical trial with a 1:1 allocation ratio. Participants will be assigned to either the experimental group, receiving active blink training via 'BlinkEasy' software, or the control group, receiving standard visual hygiene education based on the 20-20-20 rule. Randomization will be employed to ensure unbiased assignment into each study arm. The study involves a 12-week follow-up period, with clinical evaluations conducted at baseline, 4, 8, and 12 weeks to compare longitudinal changes between groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 to 40 years. * Intensive digital screen users, defined as an average screen time of ≥4 hours per day for at least 3 days per week. * Ocular Surface Disease Index (OSDI) score ≥13 (indicating mild to severe symptoms). * Non-invasive tear break-up time (NIBUT) ≤10 seconds measured by infrared meibography. * Presence of visible Meibomian glands on baseline meibography, allowing for quantitative analysis. * Technical ability to install and operate the BlinkEasy software on their primary digital device.
Exclusion criteria
* Active ocular disease, including infections, corneal ulcers, or acute conjunctivitis. * History of ocular surgery (e.g., refractive surgery, cataract extraction) or significant ocular injury. * Use of topical ophthalmic medications affecting the ocular surface (e.g., steroids, glaucoma medications, or cyclosporine) within the last 3 months. * Active use of contact lenses that cannot be suspended for the duration of the 12-week study period. * Systemic conditions known to affect the ocular surface (e.g., Sjögren's syndrome, Rheumatoid Arthritis). * Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Meibomian Gland Dropout Area and Meiboscore. | Baseline, 4 weeks, 8 weeks, and 12 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Ocular Surface Disease Index (OSDI) Score. | Baseline, 4 weeks, 8 weeks, and 12 weeks. | 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. |
| Change from Baseline in Non-Invasive Tear Break-Up Time (NIBUT). | Baseline, 4 weeks, 8 weeks, and 12 weeks. | 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. |
| Change from Baseline in Mean Blink Rate (BPM). | Weekly average throughout the 12-week study period. | 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. |
| Change from Baseline in Average Blink Duration. | Weekly average throughout the 12-week study period. | 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. |
| Reduction in Time Spent with Critical Blinking Deficiency. | Weekly total throughout the 12-week study period. | 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. |
| Adherence to the Digital Intervention. | Total accumulated over 12 weeks. | Total screen time (hours and minutes) with the software active and the total number of blink alerts triggered and acknowledged during the study. |
Contacts
CONTACTJosé Francisco Heredia González, MD
CONTACTJorge Augusto Landetta Platonoff, MD
PRINCIPAL_INVESTIGATORAna Mercedes Garcia Albisua, MD
Asociación para Evitar la Ceguera en México (APEC).
Outcome results
None listed