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

NCT07000565 | Completed

• 1 other identifier: 2855458
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Surface Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Ocular Dryness Score

  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.

  Everyday for 5 days after the inclusion of participant

• Occurence of Ocular Surface Disease

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

  1 time Everyday for 5 days after the inclusion of participant

• Change in Eyelid Closure Degree

  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.

  1 time everyday for 5 days after the inclusion of participant

Study Arms (2)

Artificial tears

EXPERIMENTAL

Every 2 hours, artificial tear solution was gently applied to the designated eye. 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. The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.

Other: Eye Care with Artificial Tears

Saline

ACTIVE COMPARATOR

Every 2 hours, saline solution (Bio-Fleks brand) was gently applied to the assigned eye for saline group.The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.

Other: Eye Care with Normal Saline

Interventions

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.

Artificial tears

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.

Saline

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having eye-related disease

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lubricant Eye Drops; Saline Solution

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Bilgi Gülseven Karabacak, MSc. PhD.

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)