Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

Peking University

Status: Enrolling

Conditions: Dry Eye

Treatments: Procedure: FS-LASIK

Study type: Observational

Funder types: Other

Identifiers

NCT05600985

DED-RS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 3 patient groups

DED after FS-LASIK

Description:

patients with dry eye disease (DED) after refractive surgery (RS）

Treatment:

Procedure: FS-LASIK

DED without FS-LASIK

Description:

patients with dry eye who did not have refractive surgery

normal control

Description:

subjects with no ocular symptoms and no previous ocular surgeries