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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFatih Sultan Mehmet Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hypoallergenic Eyelid Taping

    Procedure/Surgery

    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

    Combination product

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Eyelid Taping AloneActive comparator 1 intervention
Group B: Eyelid Taping With Lubricant Eye DropsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 hour after end of anesthesia

Secondary outcomes

1

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.

Time frame
Preoperative baseline and 1 hour after end of anesthesia
2

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.

Time frame
Preoperative baseline and 1 hour after end of anesthesia
3

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.

Time frame
2 hours and 24 hours after end of anesthesia
4

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.

Time frame
1 hour after end of anesthesia

Other outcomes

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