Blink Reminders and Meibomian Gland Loss in Digital Screen Users
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAsociación para Evitar la Ceguera en México
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Blink Reminder Software (BlinkEasy)
BehavioralParticipants 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.
Visual Hygiene Education (20-20-20 Rule).
BehavioralParticipants 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (BlinkEasy)Experimental treatment 1 intervention
Group B: Control Group (Standard Care)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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