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Starting soon Not applicable

Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection

NCT07562594 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-05-07

Condition(s) studied

Corneal InjuryExposure KeratopathyPerioperative Complications

Investigational drug(s) / intervention(s)

Hypoallergenic Eyelid TapingHypoallergenic Eyelid Taping With Lubricant Eye Drops

Hypoallergenic Eyelid Taping: Hypoallergenic surgical tape is applied horizontally across the tarsal plate of both eyes immediately after anesthesia induction and loss of lid reflex, prior to airway securing. The tape covers the entire lid margin without contacting the eyelashes. It remains in place until extubation is complete and spontaneous eye opening is confirmed.

Hypoallergenic Eyelid Taping With Lubricant Eye Drops: Preservative-free lubricant eye drops (carboxymethylcellulose 0.5%, single-dose vial) are instilled into both conjunctival fornices immediately after anesthesia induction and loss of lid reflex. Hypoallergenic surgical tape is then applied horizontally across the tarsal plate of both eyes. Tape remains in place until extubation is complete and spontaneous eye opening is confirmed.

Study summary

During general anesthesia, the eye's natural protective reflexes are suppressed, which can lead to corneal drying and injury. To prevent this, anesthesiologists routinely tape the eyelids closed. In many centers, lubricant eye drops are also applied in addition to taping, but whether this adds meaningful protection is unclear.This study will compare two approaches to eye protection during general anesthesia lasting 30 minutes to 3 hours: eyelid taping alone versus eyelid taping combined with lubricant eye drops. Two hundred adult patients undergoing elective, non-eye surgery in the supine position will be randomly assigned to one of the two groups.The main outcome is corneal surface damage measured by a standardized fluorescein staining score (NEI scale, 0-15) assessed by a blinded evaluator one hour after surgery. Secondary outcomes include tear film stability (TBUT), tear production (Schirmer test), patient-reported eye symptoms at 2 and 24 hours after surgery, and a cost-effectiveness analysis comparing the two approaches.If taping alone proves equally effective, routine use of lubricant eye drops may be unnecessary, reducing costs without compromising patient safety.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age 18 to 75 years * ASA physical status I or II * Scheduled for elective non-ocular surgery under general anesthesia * Expected anesthesia duration between 30 and 180 minutes * Supine surgical position * Ability to provide written informed consent Exclusion Criteria: * Preoperative corneal epithelial defect, keratitis, conjunctivitis, conjunctival hyperemia, or chemosis * Known ocular surface disease (dry eye syndrome, Sjögren syndrome, rheumatoid arthritis, systemic lupus erythematosus, or other systemic conditions associated with ocular surface involvement) * Use of topical or systemic medications known to affect tear production within the past 30 days * History of ocular surgery or ocular trauma * Contact lens use * Planned head and neck surgery * Prone or lateral decubitus surgical position * Patients requiring rapid sequence induction * Inability or refusal to provide written informed consent

Primary outcome measure(s)

  • Corneal Fluorescein Staining Score (NEI Scale) — 1 hour after end of anesthesia
    Corneal epithelial integrity assessed using the National Eye Institute (NEI) corneal fluorescein staining scale. The cornea is divided into 5 regions (central, inferior, superior, temporal, nasal), each scored 0-3 (0=no staining, 1=mild/sparse punctate staining, 2=moderate punctate staining, 3=severe staining/erosion). Total score ranges from 0 to 15 per eye. Evaluated by a blinded independent assessor using fluorescein strips and a cobalt blue-filtered handheld light. Right and left eyes scored separately.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07562594 on ClinicalTrials.gov ↗ ← All trials in Turkey