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

Not Applicable

Completed

• Conditions: Ocular Surface Disease

• Registration Number: NCT07000565
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Ocular Dryness Score	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.
Occurence of Ocular Surface Disease	1 time Everyday for 5 days after the inclusion of participant	Florescein testing will be used to evaluate the development of ocular surface disease
Change in Eyelid Closure Degree	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.

Trial Locations

Locations (1)

Istanbul University Istanbul Medical Faculty; 🇹🇷 Istanbul, Turkey