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

Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection During General Anesthesia: A Randomized Assessor-Blinded Trial With Cost-Effectiveness Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Complications; Corneal Injury; Exposure Keratopathy
• Intervention / Treatment: Procedure: Hypoallergenic Eyelid Taping; Combination product: Hypoallergenic Eyelid Taping With Lubricant Eye Drops

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: cansu ofluoglu, md; Phone Number: +905358640564; Email: cansuakin.iu@gmail.com
• Study Contact Backup: Name: doga meric yukselen, md; Phone Number: +905362963155; Email: d.m.boybeyi@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34000
    • Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
    • Contact: cansu ofluoglu, md; Phone Number: +905358640564; Email: cansuakin.iu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eyelid Taping Alone; Patients receive hypoallergenic surgical tape applied horizontally across the tarsal plate of both eyes immediately after anesthesia induction and loss of lid reflex. No lubricant eye drops or ointment are applied. Tape remains in place until extubation is complete.	Procedure: 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.; Other Names: Eyelid Tape; Surgical Tape Eye Protection
Experimental: Eyelid Taping With Lubricant Eye Drops; Patients receive preservative-free lubricant eye drops (carboxymethylcellulose 0.5%, single-dose vial) instilled into both conjunctival fornices immediately after anesthesia induction and loss of lid reflex, followed by hypoallergenic surgical tape applied horizontally across the tarsal plate of both eyes. Tape remains in place until extubation is complete.	Combination product: 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.; Other Names: Tape Plus Artificial Tears; Eyelid Tape With Carboxymethylcellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour after end of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperative baseline and 1 hour after end of anesthesia
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.	Preoperative baseline and 1 hour after end of anesthesia
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.	2 hours and 24 hours after end of anesthesia
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.	1 hour after end of anesthesia
Cost-Effectiveness Analysis	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.	At time of intervention (intraoperative)

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Principal Investigator: cansu ofluoglu, md, Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Cost-effectiveness; General anesthesia; Tear break-up time; Schirmer test; Lubricant eye drops; Corneal protection; Eyelid taping; Corneal fluorescein staining; NEI corneal staining scale; Perioperative eye care
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Eye Diseases; Corneal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Injuries; Facial Injuries; Corneal Injuries; Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Carbohydrates; Solutions; Specialty Uses of Chemicals; Polysaccharides; Glucans; Lubricants; Cellulose; Methylcellulose; Lubricant Eye Drops; Carboxymethylcellulose Sodium
• Other Study ID Numbers: FSMEYELİD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No