Blink Reminders and Meibomian Gland Loss in Digital Screen Users

Официальное название

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

Обзор

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).

Подробное описание

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)

Вмешательства

• Поведенческое 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 dai
• Поведенческое 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 durin

Первичные конечные точки

• Change from Baseline in Meibomian Gland Dropout Area and Meiboscore. [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks.]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Singh S, Donthineni PR, Srivastav S, Jacobi C, Basu S, Paulsen F. Lacrimal and meibomian gland evaluation in dry eye disease: A mini-review. Indian J Ophthalmol. 2023 Apr;71(4):1090-1098. doi: 10.4103/IJO.IJO_2622_22. PMID 37026239
• Daniel E, Maguire MG, Pistilli M, Bunya VY, Massaro-Giordano GM, Smith E, Kadakia PA, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study. Ocul Surf. 2019 Jul;17(3):491-501. doi: 10.1016/j.jtos.2019.04.003. Epub PMID 31022469
• Lapa I, Ferreira S, Mateus C, Rocha N, Rodrigues MA. Real-Time Blink Detection as an Indicator of Computer Vision Syndrome in Real-Life Settings: An Exploratory Study. Int J Environ Res Public Health. 2023 Mar 4;20(5):4569. doi: 10.3390/ijerph20054569. PMID 36901579
• Ashwini DL, Ve RS, Nosch D, Wilmot N. Efficacy of blink software in improving the blink rate and dry eye symptoms in visual display terminal users - A single-blinded randomized control trial. Indian J Ophthalmol. 2021 Oct;69(10):2643-2648. doi: 10.4103/ijo.IJO_3405_20. PMID 34571605
• Nosch DS, Foppa C, Toth M, Joos RE. Blink Animation Software to Improve Blinking and Dry Eye Symptoms. Optom Vis Sci. 2015 Sep;92(9):e310-5. doi: 10.1097/OPX.0000000000000654. PMID 26164310
• Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20. PMID 28736337

Идентификаторы

NCT: NCT07430137 · HGJF_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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