Investigating the Impact of RLRL on Alleviating Visual Fatigue in Presbyopic Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- change in the asthenopia questionnaire scores
研究概览
简要总结
Visual fatigue, or asthenopia, occurs when visual demands exceed the capacity of the visual system, leading to various ocular discomfort and systemic symptoms. This condition can negatively affect personal activities, quality of life, and work productivity. Given the high prevalence of asthenopia in presbyopic population, finding effective methods to alleviate these symptoms is crucial. This study aims to evaluate the effects of repeated low-level red-light (RLRL) therapy on alleviating visual fatigue in individuals with presbyopia over a one-month period. Additionally, we will assess the potential benefits on accommodation function, cognition, and emotional effects of RLRL in this population.
Interested individuals will be invited to the PolyU Optometry Clinic to undergo an eligibility examination. An estimated sample size of 66 participants will be recruited. The inclusion criteria specify individuals aged 40 years or older who self-report visual fatigue symptoms and require near correction in daily life. Exclusion criteria include those with ocular disease, systemic diseases, illiteracy, or an afterimage duration longer than 6 minutes.
Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Each participant in the intervention group will be provided an RLRL therapy device, which they are required to use twice daily for 3 minutes per session, with a minimum interval of 4 hours between sessions, 7 days a week for one month. Participants in the control group will receive a sham device, following the same usage schedule. The study will evaluate changes in asthenopia questionnaire scores, CFF scores, other objective asthenopia indicators (i.e., eye movement, pupil parameters, and blink patterns), accommodation function, cognitive function, and emotional states at 2 weeks and 1 month compared to baseline. Statistical analysis will be conducted to explore evaluate within-subject changes over time and between-group differences in visual fatigue metrics, accommodation metrics, cognitive metrics, and emotional metrics.
The findings will contribute to evaluating the effectiveness of RLRL therapy in reducing asthenopia and presbyopia symptoms, as well as its impact on cognitive function and emotional well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged over 40 years old.
- •Self-reported visual fatigue symptoms.
- •Distance best-corrected visual acuity (BCVA) of 0.5 LogMAR or better, and near visual acuity worse than N8 (20/50) at 40 cm with the subject's habitual distance correction.
- •Require near correction in daily life.
- •No light therapy received in the past six months.
- •Giving informed written consent.
排除标准
- •Presence of diseases that can cause eye pain or headaches, such as strabismus, glaucoma, ocular trauma, conjunctivitis, migraines, keratitis, iridocyclitis, or other self-reported diseases.
- •Systemic diseases (e.g., epilepsy, photosensitivity, seizure) or illiteracy.
- •Afterimage time longer than 6 minutes.
研究组 & 干预措施
RLRL therapy group
The experimental group will undergo repeated low-level red-light therapy (RLRL). The light power through a 4-mm pupil is 0.29 mW for the RLRL device.
干预措施: RLRL device (Device)
Sham therapy group
The sham group will use a sham device, which operates at only 10% of the active RLRL device's power. The light power through a 4-mm pupil is 0.03 mW for the sham device.
干预措施: sham device (Device)
结局指标
主要结局
change in the asthenopia questionnaire scores
时间窗: at 2 weeks and 1 month compared to baseline
The primary outcome is the change in the asthenopia questionnaire scores at 2 weeks and 1 month compared to baseline. These scores will be derived from the Computer Vision Syndrome Questionnaire (CVS-Q), a widely recognized tool for assessing subjective symptoms of asthenopia. The CVS-Q ranges from 0 (no symptoms) to 32 (most severe), with higher scores indicating worse symptoms (negative change = improvement)
change in the asthenopia questionnaire scores
时间窗: at 2 weeks and 1 month compared to baseline
The primary outcome is the change in the asthenopia questionnaire scores at 2 weeks and 1 month compared to baseline. These scores will be derived from the Computer Vision Syndrome Questionnaire (CVS-Q), a widely recognized tool for assessing subjective symptoms of asthenopia. The CVS-Q ranges from 0 (no symptoms) to 32 (most severe), with higher scores indicating worse symptoms (negative change = improvement)
次要结局
- Change in blink patterns(at 2 weeks and 1 month compared to baseline)
- Change in accommodation function(at 2 weeks and 1 month compared to baseline)
- Change in critical flicker fusion frequency (CFF)(at 2 weeks and 1 month compared to baseline)
- Change in eye movement(at 2 weeks and 1 month compared to baseline)
- Change in pupil parameters(at 2 weeks and 1 month compared to baseline)
- Change in blink patterns(at 2 weeks and 1 month compared to baseline)
- Change in accommodation function(at 2 weeks and 1 month compared to baseline)
- Change in self-reported emotional states(at 2 weeks and 1 month compared to baseline)
- Change in electroencephalogram (EEG)(at 2 weeks and 1 month compared to baseline)
- Change in cognitive questionnaire(at 2 weeks and 1 month compared to baseline)
- Change in critical flicker fusion frequency (CFF)(at 2 weeks and 1 month compared to baseline)
- Change in eye movement(at 2 weeks and 1 month compared to baseline)
- Change in pupil parameters(at 2 weeks and 1 month compared to baseline)
- Change in electroencephalogram (EEG)(at 2 weeks and 1 month compared to baseline)
- Change in cognitive questionnaire(at 2 weeks and 1 month compared to baseline)
- Change in self-reported emotional states(at 2 weeks and 1 month compared to baseline)
- Change in near activity visual questionnaire(at 2 weeks and 1 month compared to baseline)