The Impact of Eyelid Hygiene on Ocular Surface
1 other identifier
interventional
80
1 country
2
Brief Summary
Dry eye is one of the most common eye diseases and it is known to be an ever-increasing public health problem in risky groups. Physical conditions (heat, light, humidity,ventilation), anesthetic gases, chemical-containing disinfectants and antiseptics are risk factors for dry eyes in operating rooms. In addition, the fact that surgery is a job that requires constant attention is considered among the factors that increase the risk of dry eye as it reduces the number of blinking. In the literature review, eye hygiene (hot application, massage, cleaning) is recommended as an application that protects and improves eye health. Because it has been reported to have significant positive effects on eye fatigue, dry eye symptoms and vision in both healthy and dry eyes. However, "daily eye hygiene" is a little-known practice in almost every society. In this context, the effect of eye hygiene on ocular surface moistening and vision-related quality of life in operating room workers was investigated in this study.The research was conducted as a randomized controlled experimental study between May 2018 and May 2019. All participants working in the operating room and meeting the inclusion criteria were included in the study. The group in which the participants will be included was determined by simple randomization. Eye hygiene training was given to the intervention group and eye hygiene practice was followed for 12 weeks. The control group was not intervened. Tear film stability and vision-related quality of life scores of both groups before and after 12 weeks of training were compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedMarch 10, 2021
March 1, 2021
1 year
February 25, 2021
March 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stage ≥1 dry eye disease
Volunteers with Tear Break-up Time \<10, Schirmer-1 test \<5, Oclar Surface Disease Index score ≥ 13, McMonnies Questionnaire\> 14.5 and reporting at least one severe ocular symptom (pain, stinging, burning, stinging, itching, dryness) were considered to be at least first stage dry eye.
Weeks 0.-10.
Visual Function
Visual Function Questionnaire score 0-100
Weeks 0.-10.
Study Arms (2)
Investigation group
EXPERIMENTALEye Hygiene (warm compress, eyelid massage, and eyelid cleaning)
Control Group
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Actively working in the operating room setting, aged ≤50 years, and having Stage ≥1 dry eye disease. In a clinical examination by the ophthalmologist, volunteers with TBUT \<10, Schirmer test \<5, OSDI score ≥ 13, MQ score\> 14.5, cornea or conjunctiva\> 1 staining and reporting at least one severe ocular symptom
You may not qualify if:
- Active eye infection requiring treatment, receiving antihypertensives, antihistamines, psychogenic or chemotherapeutic agents, thyroid replacement therapy, or estrogen, having autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, diabetes, or multiple sclerosis, having a previous anterior segment surgery, wearing contact lenses, receiving treatment for dry eye disease within the past six months, receiving omega-3 or vitamin A supplements currently or within the past three months, pregnant or lactating women, and menopausal or postmenopausal women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aslı Nemli
Kayseri, Talas, 35500, Turkey (Türkiye)
Erciyes Universitesi Hastanesi
Kayseri, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aslı Nemli, PhD
Erciyes Üniversitesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 10, 2021
Study Start
June 1, 2018
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
March 10, 2021
Record last verified: 2021-03