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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining Score (NEI Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Hypoallergenic Eyelid Taping (Procedure)
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.
干预措施: Hypoallergenic Eyelid Taping With Lubricant Eye Drops (Combination Product)
结局指标
主要结局
Corneal Fluorescein Staining Score (NEI Scale)
时间窗: 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.
次要结局
- 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))
研究者
Cansu Ofluoğlu
Specialist in Anesthesiology and Reanimation
Fatih Sultan Mehmet Training and Research Hospital