NCT04789824

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

March 6, 2021

Conditions

Keywords

dryeyeoperation roomnursesurgeryeyelid hygiene

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

EXPERIMENTAL

Eye Hygiene (warm compress, eyelid massage, and eyelid cleaning)

Behavioral: eyelid hygiene

Control Group

NO INTERVENTION

No intervention

Interventions

eyelid hygieneBEHAVIORAL

EH

Investigation group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

Erciyes Universitesi Hastanesi

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Aslı Nemli, PhD

    Erciyes Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-blind, randomized-controlled
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

Locations