to analyze the clinical and tear molecular profile up to 6 months after FS-LASIK surgery
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.
Study Type
OBSERVATIONAL
Enrollment
60
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGocular surface disease index (OSDI)
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Time frame: from Pre-surgery to 6 months after surgery
Tear break-up time (TBUT)(s)
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Time frame: from Pre-surgery to 6 months after surgery
Corneal fluorescein staining (CFS)
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15.
Time frame: from Pre-surgery to 6 months after surgery
Schirmer Ⅰ test (SⅠt) (mm/5 minutes)
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of Interleukin-1β（IL-1β) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-1β levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of Interleukin-6 (IL-6) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-6 levels will be quantified by Luminex immunoassay.
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Time frame: from Pre-surgery to 6 months after surgery
the concentration of Interleukin-10 (IL-10) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-10 levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of Interleukin-23 (IL-23) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-23 levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of Interleukin-17A (IL-17A) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-17A levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. TNF-α levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of interferon-γ (IFN-γ)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IFN-γ levels will be quantified by Luminex immunoassay
Time frame: from Pre-surgery to 6 months after surgery
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. GM-CSF levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of substance P (SP)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. α-MSH levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of β-endorphin (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of neurotensin (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
the concentration of oxytocin(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay.
Time frame: from Pre-surgery to 6 months after surgery
Lissamine green staining
To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.
Time frame: from Pre-surgery to 6 months after surgery
meibomian gland dropout rate
grade 0: no gland atrophy; grade 1: ≤1/3 gland atrophy; grade 2: 1/3 to 2/3 gland atrophy；grade 3: \>2/3 gland atrophy.
Time frame: from Pre-surgery to 6 months after surgery
corneal sensitivity (range, 60-0 mm)
Corneal sensitivity will be measured in the right eye only using the Cochet-Bonnet aesthesiometer and the ascending method of limits to determine the threshold of stimulus detection.
Time frame: from Pre-surgery to 6 months after surgery
sub-basal corneal nerve density (mm/mm2)
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.
Time frame: from Pre-surgery to 6 months after surgery
numerical rating scale (NRS)
The NRS was used to evaluate ocular pain and consists of a numbered line from 0 to 10 scores that measures pain intensity: 0-1: no pain; 2-4: mild pain; 5-7: moderate pain; and 8-10: severe pain.
Time frame: from Pre-surgery to 6 months after surgery
NPSI-Eye (range 0-100 score)
Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
Time frame: from Pre-surgery to 6 months after surgery