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

Corneal abrasion is the most common perioperative ocular complication during non-ocular surgery under general anesthesia, with reported incidences of up to 44% in unprotected eyes. General anesthesia suppresses the orbicularis oculi muscle tone, blink reflex, Bell phenomenon, and lacrimal secretion, leaving the corneal surface vulnerable to exposure keratopathy. Hypoallergenic eyelid taping has become the standard preventive measure, reducing abrasion rates to less than 1%. However, many anesthesiologists additionally instill lubricant eye drops or ointments, despite limited evidence supporting this practice over taping alone.

Anesthesia duration is an independent and continuous risk factor for corneal injury, with each 10-minute increment associated with a 5% increase in risk (OR 1.05; 95% CI 1.03-1.07). Surgeries lasting 3 hours or more carry a 4.6-fold higher risk compared to shorter procedures. The present study focuses on the 30-minute to 3-hour window, which represents the majority of elective surgical caseloads and has not been directly studied with objective corneal outcome measures.

This is a prospective, randomized, assessor-blinded, two-arm parallel-group clinical trial conducted at Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation. Patients will be randomized using stratified block randomization (strata: age <50 vs ≥50 years; anesthesia duration 30-90 vs 90-180 minutes) with randomly varied block sizes of 2, 4, and 6, generated via www.sealedenvelope.com and allocated through sequentially numbered opaque sealed envelopes.

Following anesthesia induction and loss of lid reflex, all patients will receive hypoallergenic surgical tape applied horizontally across the tarsal plate of both eyes. Patients in Group 1 (Tape Only) will receive no additional intervention. Patients in Group 2 (Tape + Drops) will receive preservative-free lubricant eye drops (carboxymethylcellulose 0.5%, single-dose vial) instilled into both conjunctival fornices prior to taping.

The primary outcome, corneal fluorescein staining score (NEI scale: 5 regions × 0-3, total 0-15 per eye), will be assessed by a blinded independent evaluator (assessor) at postoperative hour 1 in the post-anesthesia care unit. Secondary outcomes include: Schirmer I test (mm/5 min) and TBUT (seconds) measured preoperatively and postoperatively; patient-reported ocular symptom VAS scores (burning, stinging, blurred vision, each 0-10) at postoperative hours 2 and 24; conjunctival hyperemia score; and a cost-effectiveness analysis including material cost per patient and total projected institutional expenditure.

Sample size was calculated based on the primary binary outcome (NEI score >0 vs. =0). Assuming a 25-30% incidence of any corneal staining in the tape-alone group and 10-12% in the tape-plus-drops group, with two-sided alpha of 0.05 and 80% power, a minimum of 74 patients per group is required. Adding 10% for dropout, the total sample size is 200 patients (100 per group), calculated using G*Power 3.1.

The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent will be obtained from all participants prior to enrollment.

• Hypoallergenic Eyelid Taping (Procedure), also known as Eyelid Tape, Surgical Tape Eye Protection: 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), also known as Tape Plus Artificial Tears, Eyelid Tape With Carboxymethylcellulose: 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.

Primary outcomes

• 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.

Secondary outcomes

• Tear Film Break-Up Time (TBUT) [Preoperative baseline and 1 hour after end of anesthesia]: 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 [Preoperative baseline and 1 hour after end of anesthesia]: 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 [2 hours and 24 hours after end of anesthesia]: 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 [1 hour after end of anesthesia]: 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.
• Cost-Effectiveness Analysis [At time of intervention (intraoperative)]: Material cost per patient calculated based on unit price of lubricant eye drops used. Total projected institutional cost compared between groups. Time required for eye drop application recorded in minutes.

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

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

• cansu ofluoglu, md, Principal investigator, ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL