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临床试验/NCT07032909
NCT07032909已完成不适用

Evaluating the Effectiveness of Comfort Reading Mode in Preventing Dry Eyes and Visual Fatigue

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Critical flicker fusion frequency

研究概览

简要总结

The purpose of this study was to investigate the effects of visual fatigue and dry eye level under different reading background polarities and different text colours, and to evaluate the effect of comfortable reading mode on the improvement of visual fatigue and dry eye level

详细描述

The effect of electronic display devices on visual fatigue of human eyes was the primary evaluation index and the primary outcome index of this experiment. Secondary outcome indicators were tear film break-up time, tear film height, and subjective visual fatigue score. Other outcome indicators were blink detection, ocular axial length measurement, accommodative function and retinal fundus blood flow. Baseline values of the above metrics were measured separately before each group of trials and then, after 45 minutes of e-text reading, specific values of the different metrics were collected when using different reading modes and all valid measurements were statistically compared and analysed. To assess the effect of comfortable reading modes on reducing visual fatigue and dry eye symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

In order to eliminate the influence of subjective factors during the examination, this study was blinded only to the examiner.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult population, regardless of gender.
  • •Refractive error is less than or equal to -2.5D and both eyes achievecorrected visual acuity of 0.8 or higher.
  • •Normal intraocular pressure with no organic pathology.
  • •No apparent symptoms of dry eye.
  • •Willing to cooperate to complete all the tests.
  • •Voluntarily signing the informed consent form.

排除标准

  • •Individuals with strabismus and amblyopia exist.
  • •Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
  • •Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
  • •Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
  • •Only one eye meets the inclusion criteria.
  • •Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
  • •Currently using medications that may lead to dry eye or affect vision and corneal curvature.
  • •Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
  • •Unable to undergo regular eye examinations.

研究组 & 干预措施

yellow background and black text mode 1 Group

Experimental

This is the group that performs visual evoked tasks using yellow background and black text mode 1. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

干预措施: comfortable reading mode (Behavioral)

yellow background and black text mode 2 Group

Experimental

This is the group that performs visual evoked tasks using yellow background and black text mode 2. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

干预措施: comfortable reading mode (Behavioral)

black background and white text mode Group

Experimental

This is the group that performs visual evoked tasks using black background and white text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

干预措施: comfortable reading mode (Behavioral)

black background and yellow text mode Group

Experimental

This is the group that performs visual evoked tasks using black background and yellow text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

干预措施: comfortable reading mode (Behavioral)

white background and black text mode Group

No Intervention

This is the group that performs visual evoked tasks using white background and black text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

结局指标

主要结局

Critical flicker fusion frequency

时间窗: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling ten completions per participant.

Critical flicker fusion frequency was measured before and after the task by a flicker fusion frequency detection device to assess changes in the degree of ocular fatigue. To compare the difference in CFF after wearing anti-blue glasses with normal glasses and to evaluate the effect of anti-blue glasses in preventing asthenopia.

次要结局

  • Visual fatigue(Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling ten completions per participant.)
  • Break up time(Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, BUT test was administered at baseline and post-task,totaling ten completions per participant.)
  • Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks(Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, AC/A test was administered at baseline and post-task,totaling ten completions per participant.)
  • equivalent refraction(Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, SE test was administered at baseline and post-task,totaling ten completions per participant.)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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