Corneal InjuryNCT07562594
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
A study testing Hypoallergenic Eyelid Taping and Hypoallergenic Eyelid Taping With Lubricant Eye Drops in people with Corneal Injury and Exposure Keratopathy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Injury, Exposure Keratopathy, Perioperative Complications
- What is being tested?
- Hypoallergenic Eyelid Taping and Hypoallergenic Eyelid Taping With Lubricant Eye Drops
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prone or lateral decubitus surgical position
- Patients requiring rapid sequence induction
- Inability or refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34000
cansu ofluoglu, md, +905358640564, cansuakin.iu@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Hypoallergenic Eyelid Taping, Hypoallergenic Eyelid Taping With Lubricant Eye Drops
- 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
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoallergenic Eyelid TapingProcedure or surgery
Also called 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 DropsCombination product
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Hypoallergenic Eyelid Taping With Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after end of anesthesia
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of intervention (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Ofluoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- cansu ofluoglu, md, Principal investigator, ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562594
- Sponsor's protocol ID
- FSMEYELİD
- Status last verified
- May 2026
- First submitted
- 25 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07562594
- Acronym / sponsor ID
- FSMEYELİD
- Keywords
- Corneal protection, General anesthesia, Eyelid taping, Lubricant eye drops, Corneal fluorescein staining, NEI corneal staining scale, Perioperative eye care, Schirmer test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Eyelid Taping Alone | Active comparator | Procedure: Hypoallergenic Eyelid TapingPatients 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. |
| Eyelid Taping With Lubricant Eye Drops | Experimental | Combination Product: Hypoallergenic Eyelid Taping With Lubricant Eye DropsPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoallergenic Eyelid TapingAlso: Eyelid Tape, Surgical Tape Eye ProtectionHypoallergenic 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. | Procedure or surgery | Eyelid Taping Alone |
| Hypoallergenic Eyelid Taping With Lubricant Eye DropsAlso: Tape Plus Artificial Tears, Eyelid Tape With CarboxymethylcellulosePreservative-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. | Combination product | Eyelid Taping With Lubricant Eye Drops |
Primary outcome
Corneal Fluorescein Staining Score (NEI Scale)
Time frame: 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.
5 secondary outcomes
Tear Film Break-Up Time (TBUT)
Time frame: Preoperative baseline and 1 hour after end of anesthesia
Schirmer I Test
Time frame: Preoperative baseline and 1 hour after end of anesthesia
Patient-Reported Ocular Symptom VAS Score
Time frame: 2 hours and 24 hours after end of anesthesia
Conjunctival Hyperemia Score
Time frame: 1 hour after end of anesthesia
Cost-Effectiveness Analysis
Time frame: At time of intervention (intraoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
cansu ofluoglu, md principal investigator
ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoallergenic Eyelid Taping and Hypoallergenic Eyelid Taping With Lubricant Eye Drops in people with Corneal Injury and Exposure Keratopathy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cansu ofluoglu, md (+905358640564, cansuakin.iu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Fluorescein Staining Score (NEI Scale) (time frame: 1 hour after end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.