Blink Reminders and Meibomian Gland Loss in Digital Screen Users

February 25, 2026 updated by: Asociación para Evitar la Ceguera en México

Effect of a Blink Reminder Program on the Progression of Meibomian Gland Loss in Intensive Digital Screen Users: a Randomized Controlled Trial With Infrared Meibography

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (BlinkEasy)
Users assigned to this arm will use the 'BlinkEasy' software for 12 weeks.
Behavioral: Digital 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.
Other Names:
  • Active Blink Reminder Program
  • Automated Blink Training Software
  • Computer-based Blink Alert System
Active Comparator: Control Group (Standard Care)
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 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.
Other Names:
  • 20-20-20 Rule
  • Visual Hygiene Education
  • Standard Ergonomic Advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Meibomian Gland Dropout Area and Meiboscore.
Time Frame: 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.
Baseline, 4 weeks, 8 weeks, and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Ocular Surface Disease Index (OSDI) Score.
Time Frame: 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.
Baseline, 4 weeks, 8 weeks, and 12 weeks.
Change from Baseline in Non-Invasive Tear Break-Up Time (NIBUT).
Time Frame: 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.
Baseline, 4 weeks, 8 weeks, and 12 weeks.
Change from Baseline in Mean Blink Rate (BPM).
Time Frame: 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.
Weekly average throughout the 12-week study period.
Change from Baseline in Average Blink Duration.
Time Frame: 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.
Weekly average throughout the 12-week study period.
Reduction in Time Spent with Critical Blinking Deficiency.
Time Frame: 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.
Weekly total throughout the 12-week study period.
Adherence to the Digital Intervention.
Time Frame: 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.
Total accumulated over 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Ana Mercedes Garcia Albisua, MD, Asociación para Evitar la Ceguera en México (APEC).

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGJF_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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