Clinical trial NCT05601011: Changes of Clinical Characteristics and Tear Film Biomarkers Following FS-LASIK
Official title: Changes of Clinical Characteristics and Tear Film Biomarkers Following FS-LASIK
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from Peking University Third Hospital

Brief summary: to analyze the clinical and tear molecular profile up to 6 months after FS-LASIK surgery

Detailed description: FS-LASIK is a refractive surgery technique widely used in China. To explore the role of inflammation and nerve in the occurrence and development of dry eyes after FS-LASIK by dynamically observing the ocular surface characteristics and the levels of inflammatory factors and neurotransmitters in the early and late stage after FS-LASIK.

Eligibility criteria: Inclusion Criteria:

1. Patients who preparing for FS-LASIK with age between 18 and 45 years old
2. Any gender
3. Provision of written informed consent.

Exclusion Criteria:

1. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
2. Pregnant and lactating women, or those planning a pregnancy over the course of the study
3. Uncontrolled systemic disease
4. Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

Primary outcomes:
measure: ocular surface disease index (OSDI)
timeFrame: from Pre-surgery to 6 months after surgery
measure: Tear break-up time (TBUT)(s)
timeFrame: from Pre-surgery to 6 months after surgery
measure: Corneal fluorescein staining (CFS)
timeFrame: from Pre-surgery to 6 months after surgery
measure: Schirmer Ⅰ test (SⅠt) (mm/5 minutes)
timeFrame: from Pre-surgery to 6 months after surgery
Secondary outcomes:
measure: the concentration of Interleukin-1β（IL-1β) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of Interleukin-6 (IL-6) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of Interleukin-10 (IL-10) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of Interleukin-23 (IL-23) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of Interleukin-17A (IL-17A) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of interferon-γ (IFN-γ)(pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of substance P (SP)(pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of β-endorphin (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of neurotensin (pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: the concentration of oxytocin(pg/ml)
timeFrame: from Pre-surgery to 6 months after surgery
measure: Lissamine green staining
timeFrame: from Pre-surgery to 6 months after surgery
measure: meibomian gland dropout rate
timeFrame: from Pre-surgery to 6 months after surgery
measure: corneal sensitivity (range, 60-0 mm)
timeFrame: from Pre-surgery to 6 months after surgery
measure: sub-basal corneal nerve density (mm/mm2)
timeFrame: from Pre-surgery to 6 months after surgery
measure: numerical rating scale (NRS)
timeFrame: from Pre-surgery to 6 months after surgery
measure: NPSI-Eye (range 0-100 score)
timeFrame: from Pre-surgery to 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: