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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Change from Baseline in Meibomian Gland Dropout Area and Meiboscore.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Experimental Group (BlinkEasy)
Users assigned to this arm will use the 'BlinkEasy' software for 12 weeks.
干预措施: Digital Blink Reminder Software (BlinkEasy) (Behavioral)
Control Group (Standard Care)
Users in this arm will follow the 20-20-20 visual hygiene rule for 12 weeks.
干预措施: Visual Hygiene Education (20-20-20 Rule). (Behavioral)
结局指标
主要结局
Change from Baseline in Meibomian Gland Dropout Area and Meiboscore.
时间窗: 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.
次要结局
- Change from Baseline in Ocular Surface Disease Index (OSDI) Score.(Baseline, 4 weeks, 8 weeks, and 12 weeks.)
- Reduction in Time Spent with Critical Blinking Deficiency.(Weekly total throughout the 12-week study period.)
- Change from Baseline in Non-Invasive Tear Break-Up Time (NIBUT).(Baseline, 4 weeks, 8 weeks, and 12 weeks.)
- Change from Baseline in Mean Blink Rate (BPM).(Weekly average throughout the 12-week study period.)
- Change from Baseline in Average Blink Duration.(Weekly average throughout the 12-week study period.)
- Adherence to the Digital Intervention.(Total accumulated over 12 weeks.)