Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04789824 |
| Other study ID # |
surgerynurse |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
September 1, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Saglik Bilimleri Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Dry eye disease is one of the most common pathologies of the ocular surface which is
characterized by tear film instability due to insufficient tear production or increased
evaporation. Its prevalence varies between 5 to 50% in adults and may increase up to 75% in
individuals aged above 40 years. This disease affects women twice as often as men. Dry eye
poses burden on patients, due to associated symptoms that may widely range from persistent
pain, itching, burning, stinging or scratchy and foreign body sensation, and light
sensitivity to blurred vision, corneal epithelial defects, and ulcerations in the chronic
state. In particular, in moderate-to-severe cases, pain, limitations in the daily living
activities, and reduced quality of life are associated with depression, mood and sleep
disorders. There are many factors proposed to play a role in the etiology of the disease:
lifestyle habits, low humidity and artificial indoor heating and air conditioning systems,
environmental factors such as air pollution containing chemical, physical, and biological
pollutants, visual tasks requiring long-term mental focus, prolonged exposure to computer or
smart phones, and occupational and personal habits that decrease the eyeblink frequency and
increase the ocular evaporation.
The operating rooms are specially designed for multi-modality use and contain a number of
environmental pollutants for the ocular surface associated with the physical environment and
occupational and personal habits of healthcare providers. Surgery itself being a critical
task demanding long-term mental focus, air conditioning, constant humidity, constant room
temperature, intense lighting, irritant chemicals, surgical smoke, anesthetic gases, and
biological aerosols are predisposing factors for ocular irritation in operating room staff. A
few studies demonstrated that the risk of dry eye disease is higher in operating room staff,
intensive care nursing and laboratory technicians. Castellanos-González et al. reported that
their presence in the operating room predisposed surgical residents to have dry eye syndrome
due to environmental conditions.
To the best of our knowledge, there is no study investigating the effectiveness of proper
eyelid hygiene in dry eye disease among operating room staff., occupational activities with a
high level of visual burden, and working environment. Dry eye disease is a chronic and
progressive condition. Treatment provides symptomatic relief; however, cure is seen in only a
small fraction of patients. The 2017 Tear Film and Ocular Surface Society (TFOS) revisited
the management and treatment of dry eye disease in a two-step model. Accordingly, in the
first step, non-pharmacological methods such as education about the disease and its
management, modification of local environment, dietary changes, increasing fluid intake,
enhanced blinking behavior, and proper eyelid hygiene are recommended. Based on these
recommendations, eyelid hygiene regimen consisting of warm compress, lid massage, and eye
cleaning is a supportive and rehabilitative approach. Also, studies have revealed that have
also demonstrated the favorable effects of daily eyelid hygiene consisting of warm compress,
lid massage, and cleaning on eye fatigue, dry eye symptoms, and visual acuity and recommended
this regimen as a preventive medicine and health promotion. Warm compress and mechanical lid
massage induce the meibomian secretion (i.e., the tear film lipid layer is mostly (90%)
derived from the meibomian oil secreted by the meibomian glands), while eye cleaning provides
protein/lipid deposits around the eyelashes and eyelids and eliminates microbial agents such
as Staphylococci and Demodex spp.
Previous studies have confirmed the increased the secretion of meibomian lipids that are
pathologically altered with warm compress, the outcomes may vary depending on the duration of
application, degree of heat, and patient compliance. It have shown that the mean temperature
ranges between 37.7±0.3 and 41.6±1.0°C and the ideal temperature is 40 to 45°C for warm
compress. Once the meibomian secretions are liquefied with warm compress, the main goal of
lid massage is to reduce the clogging of the meibomian gland and to maintain sufficient
drainage of the tears. Following eyelid warming for minimum four min once or twice daily,
medium-to-intense eyelid massage has been shown to induce expression of the meibomian gland
secretions. With similar effects to mechanical finger massage, intense pulsed light to the
eyelid, high-frequency electrotherapy, meibomian gland compressors, and eye massagers with
heat-vibration have been also utilized in studies. Previous studies have confirmed that eye
clean is an effective approach to prevent meibomian gland dysfunction (MGD) and Demodex
mites. The most common used eye clean regimens include warm water in a washcloth, soaked
cloths, cotton pads, or cotton tipped applicators, and gentle rubbing with baby shampoo,
alone or combined.
In the present study, we, for the first time, aimed to evaluate the impact of eyelid hygiene
on tear film stability, ocular symptoms, and vision-related quality of life among operating
room staff with Stage ≥I dry eye disease.
