Evaporative Dry Eye
Conditions
Brief summary
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.
Detailed description
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: 1. Study group. 2. 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.
Interventions
OTHERPreservative free hyaluronic acid artificial tear
Ocular lubricant
Sponsors
Crossdata
Laboratorios Thea, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Patient Evaluation of Eye Dryness (SPEED) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Breakup Time (TBUT) | Between Day 1 and Day 3 | Change in Tear Breakup Time (TBUT) score (normal values \> or equal to 10 seconds) between study and control group |
| Conjunctival staining with lisamine green measured with Oxford scale | Between Day 1 and Day 3 | Change in conjunctival oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group |
| Corneal staining with fluorescein measured with Oxford scale | Between Day 1 and Day 3 | Change in corneal oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group |
| Conjunctival hyperemia measured with McMonnies Chapman scale | Between Day 1 and Day 3 | Change in McMonnies Chapman score (range 0-5, with higher scores indicative of more conjunctival hyperemia) between study and control group |
| Near convergence measured with a RAF binocular gauge | Between Day 1 and Day 3 | Change in near convergence between study and control group |
| Accomodation distance measured with a RAF binocular gauge | Between Day 1 and Day 3 | Change in accomodation distance between study and control group |
| Schirmer I tear volume test | Between Day 1 and Day 3 | Change in Schirmer score (normal values equal or higher than 10) between study and control group |
Countries
Spain
Outcome results
None listed