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Not Yet RecruitingNCT07430137

Blink Reminders and Meibomian Gland Loss in Digital Screen Users

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
Asociación para Evitar la Ceguera en México · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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)

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2026-02-19
Primary completion
2026-06-01
Completion
2026-08-01
First posted
2026-02-24
Last updated
2026-02-27

Source: ClinicalTrials.gov record NCT07430137. Inclusion in this directory is not an endorsement.