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Completed

NCT Number: NCT05536661

Impact of Tear Substitute Use on Dry Eye in Gamers.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dreamhack Convention

Valencia, 46035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preservative free hyaluronic acid artificial tear

Other

Ocular lubricant

Primary outcomes

  1. Standard Patient Evaluation of Eye Dryness (SPEED)

    Time frame: 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 outcomes

  1. Conjunctival hyperemia measured with McMonnies Chapman scale

    Time frame: 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

  2. Tear Breakup Time (TBUT)

    Time frame: 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

  3. Conjunctival staining with lisamine green measured with Oxford scale

    Time frame: 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

  4. Corneal staining with fluorescein measured with Oxford scale

    Time frame: 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

  5. Schirmer I tear volume test

    Time frame: Between Day 1 and Day 3

    Change in Schirmer score (normal values equal or higher than 10) between study and control group

  6. Near convergence measured with a RAF binocular gauge

    Time frame: Between Day 1 and Day 3

    Change in near convergence between study and control group

  7. Accomodation distance measured with a RAF binocular gauge

    Time frame: Between Day 1 and Day 3

    Change in accomodation distance between study and control group

Sponsors and collaborators

Lead sponsor

Laboratorios Thea, Spain

Industry

Collaborators

  • Crossdata

Registry information

Official study title

Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.

Acronym: HYAGAME

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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