About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Hypoallergenic Eyelid Taping
Procedure/SurgeryHypoallergenic 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
Combination productPreservative-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.
Treatment groups
Trial outcomes
Primary outcomes
Corneal Fluorescein Staining Score (NEI Scale)
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.
Secondary outcomes
Tear Film Break-Up Time (TBUT)
Time in seconds from last blink to first appearance of a dry spot in the tear film, assessed using fluorescein strip and cobalt blue light. Measured in both eyes separately. Three measurements averaged per eye.
Schirmer I Test
Basal tear production measured by Schirmer strip placed in the temporal one-third of the lower conjunctival fornix without topical anesthesia. Strip wetness read in millimeters after 5 minutes. Measured in both eyes separately.
Patient-Reported Ocular Symptom VAS Score
Three ocular symptoms assessed separately using a Visual Analog Scale (VAS) from 0 (none) to 10 (worst imaginable): burning, stinging, and blurred vision. Scores recorded individually for each symptom.
Conjunctival Hyperemia Score
Conjunctival hyperemia graded on a 0-3 scale (0=none, 1=mild, 2=moderate, 3=severe) by the blinded independent assessor in both eyes separately.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: