NCT05536661已完成不适用
Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
Laboratorios Thea, Spain2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Standard Patient Evaluation of Eye Dryness (SPEED)
研究概览
简要总结
Clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (Hyabak) versus no intervention.
详细描述
Adult attendees to a Gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. Participants will be randomized into 2 groups of equal size:
- Study group.
- Control group. The Study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days.
- •Voluntarily accept to participate and sign informed consent form
排除标准
- •Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
- •History of ocular trauma or infecction in the last 3 months previous to inclusion.
- •History of refractive surgery.
- •Visual acuity 0.5 or less in at least 1 eye.
- •Ocular medication use in the 3 days prior to inclusion.
- •History of systemic condition asociated to dry eye.
- •Use of systemic medication known to induce dry eye in the last 30 days.
- •Known allergy to hyaluronic acid.
- •Pregnant or lactating women.
结局指标
主要结局
Standard Patient Evaluation of Eye Dryness (SPEED)
时间窗: Between Day 1 and Day 3
Change in Standard Patient Evaluation of Eye Dryness (SPEED) score between study and control group (range 0-28, with higher scores indicative of dry eye disease symptoms)
次要结局
- Tear Breakup Time (TBUT)(Between Day 1 and Day 3)
- Accomodation distance measured with a RAF binocular gauge(Between Day 1 and Day 3)
- Conjunctival staining with lisamine green measured with Oxford scale(Between Day 1 and Day 3)
- Corneal staining with fluorescein measured with Oxford scale(Between Day 1 and Day 3)
- Near convergence measured with a RAF binocular gauge(Between Day 1 and Day 3)
- Conjunctival hyperemia measured with McMonnies Chapman scale(Between Day 1 and Day 3)
- Schirmer I tear volume test(Between Day 1 and Day 3)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Dry Eye Disease: assessment of existing diagnostic methodsdry eye disease10021877NL-OMON53487Amsterdam UMC17
Unknown
不适用
Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF InjectionsDry Eye SyndromesNCT06317922Francesco Bandello60
招募中
不适用
The pilot study of Eye and surround the eye nerve stimulation after LASEK(Laser Asisted Sub-Epithelial Keratomileusis) with dry eye.KCT0004602u Eyne24
已完成
不适用
Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects With Moderate Dry EyeTear Film InsufficiencyDry Eye SyndromeNCT02510235Dompé Farmaceutici S.p.A56
已完成
不适用
An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)Dry EyeNCT06443775AbbVie47