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OpenTrials
Completed

NCT Number: NCT07000565

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

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.

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Key information

Conditions

Ocular Surface Disease

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye Care with Artificial Tears

Other

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.

Eye Care with Normal Saline

Other

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

Primary outcomes

  1. Change in Ocular Dryness Score

    Time frame: Everyday for 5 days after the inclusion of participant

    Ocular 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.

  2. Occurence of Ocular Surface Disease

    Time frame: 1 time Everyday for 5 days after the inclusion of participant

    Florescein testing will be used to evaluate the development of ocular surface disease

  3. Change in Eyelid Closure Degree

    Time frame: 1 time everyday for 5 days after the inclusion of participant

    Eyelid 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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