Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Corneal Protection During General Anesthesia: A Randomized Controlled Trial

NCT07562594 | Not Yet Recruiting

• 1 other identifier: FSMEYELİD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Injury; Exposure Keratopathy; Perioperative Complications

Keywords

Corneal protection; General anesthesia; Eyelid taping; Lubricant eye drops; Corneal fluorescein staining; NEI corneal staining scale; Perioperative eye care; Schirmer test; Tear break-up time; Cost-effectiveness; Randomized controlled trial

Outcome Measures

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.

  1 hour after end of anesthesia

Secondary Outcomes (5)

• Tear Film Break-Up Time (TBUT)

  Preoperative baseline and 1 hour after end of anesthesia

• Schirmer I Test

  Preoperative baseline and 1 hour after end of anesthesia

• Patient-Reported Ocular Symptom VAS Score

  2 hours and 24 hours after end of anesthesia

• Conjunctival Hyperemia Score

  1 hour after end of anesthesia

• Cost-Effectiveness Analysis

  At time of intervention (intraoperative)

Study Arms (2)

Eyelid Taping Alone

ACTIVE COMPARATOR

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

Eyelid Taping With Lubricant Eye Drops

EXPERIMENTAL

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

Interventions

Hypoallergenic Eyelid Taping PROCEDURE

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.

Also known as: Eyelid Tape, Surgical Tape Eye Protection

Eyelid Taping Alone

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.

Also known as: Tape Plus Artificial Tears, Eyelid Tape With Carboxymethylcellulose

Eyelid Taping With Lubricant Eye Drops

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Corneal Injuries

Interventions

Lubricant Eye Drops; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• cansu ofluoglu, md

  ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cansu ofluoglu, md

CONTACT

+905358640564; cansuakin.iu@gmail.com

doga meric yukselen, md

CONTACT

+905362963155; d.m.boybeyi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome (NEI corneal fluorescein staining score) is assessed by an independent evaluator who is blinded to group allocation throughout the study. Participants are blinded to group assignment as the intervention is applied under general anesthesia. The treating anesthesiologist (care provider) is not blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Model Details: Two parallel arms: eyelid taping alone (Group 1) versus eyelid taping combined with preservative-free lubricant eye drops (Group 2). Participants are randomized 1:1 using stratified block randomization.

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

TU (1)