Dry EyeNCT04789824
The Impact of Eyelid Hygiene on Ocular Surface
A study testing eyelid hygiene in people with Dry Eye, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- eyelid hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aslı Nemli
Kayseri, Talas, 35500
Erciyes Universitesi Hastanesi
Kayseri
About this study
Official title: The Impact of Eyelid Hygiene on Ocular Surface Among Opeartion Room Staff
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.
Read the detailed 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.
- Conditions
- Dry Eye
- Being tested
- eyelid hygiene
- Keywords
- dryeye, operation room, nurse, surgery, eyelid hygiene
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyelid hygieneBehavioural
EH
| Study group | Role | What they receive |
|---|---|---|
| Investigation group | Experimental | Eye Hygiene (warm compress, eyelid massage, and eyelid cleaning) Receives: Behavioral: eyelid hygiene |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0.-10.
Visual Function
Visual Function Questionnaire score 0-100
Measured: Weeks 0.-10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized-controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Nemli, Saglik Bilimleri Universitesi
- Investigators
- Aslı Nemli, PhD, Study director, Erciyes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789824
- Sponsor's protocol ID
- surgerynurse
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Eyelid Hygiene on Ocular Surface Among Opeartion Room Staff
- ClinicalTrials.gov ID
- NCT04789824
- Acronym / sponsor ID
- surgerynurse
- Conditions
- Dry Eye
- Keywords
- dryeye, operation room, nurse, surgery, eyelid hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, randomized-controlled
| Arm | Type | Receives |
|---|---|---|
| Investigation group | Experimental | Behavioral: eyelid hygieneEye Hygiene (warm compress, eyelid massage, and eyelid cleaning) |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eyelid hygieneEH | Behavioural | Investigation group |
Primary outcome
Stage ≥1 dry eye disease
Time frame: Weeks 0.-10.
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.
Visual Function
Time frame: Weeks 0.-10.
Visual Function Questionnaire score 0-100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı Nemli, PhD study director
Erciyes Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eyelid hygiene in people with Dry Eye, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage ≥1 dry eye disease (time frame: Weeks 0.-10.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.