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The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients

The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07000565
Enrollment
42
Registered
2025-06-03
Start date
2024-11-01
Completion date
2025-01-01
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Surface Disease

Keywords

ocular surface disease, eye care, pediatric intensive care, nursing, artificial tears, saline

Brief summary

The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Based on the findings, the study seeks to provide evidence-based contributions to nursing practices. Additionally, it aims to identify educational strategies to enhance intensive care nurses' knowledge and practice levels and to support the development of clinical care protocols. H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients. H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients. H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.

Interventions

OTHEREye Care with Artificial Tears

Every 2 hours, the artificial tear solution was gently applied to the designated eye for 5 days. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation.

OTHEREye Care with Normal Saline

Every 2 hours, the saline solution(Bio-Fleks brand) was gently applied to the designated eye for 5 days.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 28 days to 18 years * Receiving invasive mechanical ventilation * Admitted to the pediatric intensive care unit * Parent(s) or legal guardian(s) provide informed consent for participation

Exclusion criteria

-Having eye-related disease

Design outcomes

Primary

MeasureTime frameDescription
Change in Ocular Dryness ScoreEveryday for 5 days after the inclusion of participantOcular dryness will be measured using the Schirmer test.The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
Occurence of Ocular Surface Disease1 time Everyday for 5 days after the inclusion of participantFlorescein testing will be used to evaluate the development of ocular surface disease
Change in Eyelid Closure Degree1 time everyday for 5 days after the inclusion of participantEyelid Closure Degree was evaluated by clinical observation and scoring (e.g., staining intensity and affected area). The score was compared between the eye treated with artificial tears and the eye treated with normal saline.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026