Changes of Clinical Characteristics and Tear Film Biomarkers Following FS-LASIK

Recruiting

• Conditions: Dry Eye

• Registration Number: NCT05601011
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-29
• Study Start: 2022-10-31
• Study First Posted: 2022-11-01
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocular surface disease index (OSDI)	from Pre-surgery to 6 months after surgery	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.
Tear break-up time (TBUT)(s)	from Pre-surgery to 6 months after surgery	BUT is the time from normal blinking to the first appearance of a break in the tear film.
Corneal fluorescein staining (CFS)	from Pre-surgery to 6 months after surgery	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.
Schirmer Ⅰ test (SⅠt) (mm/5 minutes)	from Pre-surgery to 6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
the concentration of Interleukin-6 (IL-6) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of β-endorphin (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of Interleukin-17A (IL-17A) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of interferon-γ (IFN-γ)(pg/ml)	from Pre-surgery to 6 months after surgery	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
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of substance P (SP)(pg/ml)	from Pre-surgery to 6 months after surgery	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay.
the concentration of neurotensin (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of oxytocin(pg/ml)	from Pre-surgery to 6 months after surgery	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay.
NPSI-Eye (range 0-100 score)	from Pre-surgery to 6 months after surgery	Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
the concentration of Interleukin-1β（IL-1β) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of Interleukin-10 (IL-10) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of Interleukin-23 (IL-23) (pg/ml)	from Pre-surgery to 6 months after surgery	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.
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)	from Pre-surgery to 6 months after surgery	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.
numerical rating scale (NRS)	from Pre-surgery to 6 months after surgery	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.
Lissamine green staining	from Pre-surgery to 6 months after surgery	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.
meibomian gland dropout rate	from Pre-surgery to 6 months after surgery	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.
corneal sensitivity (range, 60-0 mm)	from Pre-surgery to 6 months after surgery	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.
sub-basal corneal nerve density (mm/mm2)	from Pre-surgery to 6 months after surgery	Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China