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A Non-inferiority Study on Tear Film Protection with Perfluorohexyloctane Eye Drops versus Hydrogel Dressings in Patients Undergoing General Anesthesia

A Non-inferiority Study on Tear Film Protection with Perfluorohexyloctane Eye Drops versus Hydrogel Dressings in Patients Undergoing General Anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116683
Enrollment
Unknown
Registered
2026-01-13
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure Keratopathy

Interventions

Perfluorohexyloctane Eye Drops Arm:Following the establishment of satisfactory anesthesia, the study eye received instillation of the medication every two hours until the end of the surgery.
Transparent Dressing Eyelid Closure Arm:Following the establishment of satisfactory anesthesia, the control eye received transparent dressing eyelid closure until the end of the surgery.

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, male or female. 2. Patients scheduled for supine general anesthesia surgery (non-ocular and non-head/neck surgery), with the surgical preparation area not involving the periorbital skin, and allowing for convenient administration of the medication during the procedure. 3. Patients voluntarily agree to participate in this study and are able to cooperate throughout the entire research process.

Exclusion criteria

Exclusion criteria: 1. Patients with acute ocular diseases (e.g., conjunctivitis, keratitis) or pre-existing lagophthalmos. 2. Patients using topical ophthalmic medications that will be continued during the perioperative period, such as anti-glaucoma agents or artificial tears. 3. Patients who have undergone ocular surgery within the past 3 months. 4. Long-term contact lens wearers, or patients with pre-existing severe ocular conditions that would interfere with ocular examinations. 5. Patients with severe Graft-versus-Host Disease (GVHD), Sjögren's syndrome, Stevens-Johnson syndrome, or similar conditions. 6. Pregnancy. 7. Patients unable to cooperate with the required examinations and follow-up visits. 8. Anticipated surgical duration >12 hours or expected intraoperative blood transfusion >2500 ml. 9. Any other condition deemed by the investigator to make the patient unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Dry Eye Symptom VAS Score;Tear Film Break-Up Time (TBUT);Corneal Fluorescein Staining Score;

Secondary

MeasureTime frame
Slit-Lamp Examination;Schirmer's test;Tear Fluid Biomarker;Conjunctival Hyperemia Score;Vision;Tear Meniscus Height (TMH);Meibomian Gland Area Score;Corneal clarity;Status of the eyelid skin;

Countries

China

Contacts

Public ContactLi Li

The First Affiliated Hospital of Xi'an Jiaotong University

eyelilixjtu@xjtu.edu.cn+86 150 2908 3873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026