Reading; Through the Eyes of a University Student. A Double-masked, Randomised Control Trial to Assess the Effect of Precision Tinted Spectacle Filters on Visual Stress Symptoms Within the University Student Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Symptoms
研究概览
简要总结
This is a double-masked randomized controlled trial which aims to assess the effects of precision tinted spectacle lenses on visual stress symptoms within an undergraduate University student population.
详细描述
The participants will be recruited from the undergraduate Ulster University student population. Those students who have been identified as potentially having visual stress will be invited to undergo screening tests to assess their eligibility to participate in the randomized controlled trial.
Visit 1:
Each consenting participant will undergo tests to assess their eligibility to participate in this study.
Provided the participant meets the inclusion criteria then they will undergo a baseline eye examination and reading tests including the Wilkins Rate of Reading test (WRRT).
The participant will then undergo colorimetry testing using the Intuitive colorimeter (Cerium TM) using the established procedure to individually measure the optimum chromaticity which alleviates visual stress symptoms for each participant. This will be the 'experimental' colour. A second colour will be measured at which visual stress symptoms will be present, this colour will not be aversive to the participant and will be as close to the 'experimental' colour as possible to aid masking. This will be the 'control' colour and it will be individually determined for each participant. Participants and researchers will be masked to which spectacles are 'control' and 'experimental' throughout the course of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The researcher will perform colorimetry testing to measure the chromaticity of the 'experimental' and 'control' coloured lenses.The 'experimental' and 'control' colour will be as similar in chromaticity as possible. The details of the 'experimental' and 'control' colour will be given to an external person who will randomly assign the order in which the spectacles will be collected by the participant. There is a significant time lapse between the colorimetry assessment where the 'experimental' and 'control' colours are measured and the collection of the first pair of spectacles.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consenting undergraduate University students, studying at Ulster University who have visual stress symptoms.
排除标准
- •Reduced visual acuity
- •Uncorrected spectacle prescription
- •Decompensating heterophoria
- •Heterotropia
- •Accommodative insufficiency
- •Convergence insufficiency
- •Ocular health abnormality
- •Any participant currently using precision tinted lenses
研究组 & 干预措施
'Experimental' coloured spectacle lenses
Precision tinted lenses available from Cerium Technologies (TM) which will be the optimum chromaticity to alleviate visual stress symptoms. To be worn for a minimum of 10 weeks for concentrated tasks.
干预措施: Precision tinted spectacle lenses (Device)
'Control' coloured spectacle lenses
Precision tinted lenses available from Cerium Technologies (TM) which will be individually determined as being sub-optimal to alleviate visual stress symptoms. This colour will be as similar to the 'experimental' colour as possible and will not be aversive to the participant. To be worn for a minimum of 10 weeks for concentrated tasks.
干预措施: Precision tinted spectacle lenses (Device)
结局指标
主要结局
Symptoms
时间窗: 12 weeks
Symptom diary to be completed by the participant daily for the first and final week of wear of each pair of spectacles. The participant will be asked details about how much reading they have performed, how long they have worn the spectacles for and if they have experienced any symptoms of visual perceptual distortions.
Reading rate
时间窗: 12 weeks
Wilkins rate of reading test
次要结局
- Voluntary use of coloured spectacles(3 months)