Clinical trial NCT05600985: Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery
Official title: Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from Peking University Third Hospital

Brief summary: In recent years, many scholars have studied the ocular surface damage of patients with dry eye disease（DED）after FS-LASIK, but there has been a lack of comprehensive observation and research on the relationship and difference between dry eye （DE）patients with and without LASIK. Therefore, the purpose of this study was to investigate the characteristics of ocular surface and cytokines after FS-LASIK, and further explain the pathogenesis of chronic dry eyes after FS-LASIK. In addition, we will also compare clinical characteristics and tear neuropeptide concentrations in patients with dry eye disease (DED) with and without chronic ocular pain following FS-LASIK, and to investigate correlations between ocular pain, clinical characteristics, and tear neuropeptide levels.

Detailed description: A single visit cross-sectional study was performed. Approximately 40 chronic dry eye participants who had FS-LASIK more than 12month prior were recruited. Approximately 40 dry eye participants without refractive surgery history and 40 healthy participants without dry eye were also recruited as control groups. In addition, the patients with post-FS-LASIK DED were categorized into two groups based on the presence or absence of chronic ocular pain: (1) post-FS-LASIK DED patients with chronic ocular pain and (2) post-FS-LASIK DED patients without chronic ocular pain.

Eligibility criteria: Inclusion Criteria:

1. Age 18years to 40 years
2. Male or female
3. DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without FS-LASIK
4. 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, which in the judgment of the investigator may interfere with the interpretation of the study results.
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: baseline
measure: numerical rating scale (NRS)
timeFrame: baseline
measure: NPSI-Eye (range 0-100 score)
timeFrame: baseline
measure: Tear break-up time (TBUT)(s)
timeFrame: baseline
measure: Corneal fluorescein staining (CFS)
timeFrame: baseline
Secondary outcomes:
measure: the concentration of Interleukin-1β（IL-1β) (pg/ml)
timeFrame: baseline
measure: the concentration of Interleukin-6 (IL-6) (pg/ml)
timeFrame: baseline
measure: the concentration of Interleukin-10 (IL-10) (pg/ml)
timeFrame: baseline
measure: the concentration of Interleukin-23 (IL-23) (pg/ml)
timeFrame: baseline
measure: the concentration of Interleukin-17A (IL-17A) (pg/ml)
timeFrame: baseline
measure: the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
timeFrame: baseline
measure: the concentration of interferon-γ (IFN-γ)(pg/ml)
timeFrame: baseline
measure: the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
timeFrame: baseline
measure: the concentration of substance P (SP)(pg/ml)
timeFrame: baseline
measure: the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
timeFrame: baseline
measure: the concentration of β-endorphin (pg/ml)
timeFrame: baseline
measure: the concentration of neurotensin(pg/ml)
timeFrame: baseline
measure: the concentration of oxytocin(pg/ml)
timeFrame: baseline
measure: Schirmer Ⅰ test (SⅠt) (mm/5 minutes)
timeFrame: baseline
measure: tear meniscus height (TMH)(mm)
timeFrame: baseline
measure: Lissamine green staining
timeFrame: baseline
measure: meibomian gland dropout rate
timeFrame: baseline
measure: corneal sensitivity (range, 60-0 mm)
timeFrame: baseline
measure: sub-basal corneal nerve density (mm/mm2)
timeFrame: baseline
measure: Hamilton anxiety scale
timeFrame: baseline
measure: Hamilton Depression scale
timeFrame: baseline
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
affiliation: Peking University Third Hospital
name: Lu Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: