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Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

China120 participantsStarted 2022-10-29

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18years to 40 years
✓. Male or female
✓. DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without FS-LASIK
✓. Provision of written informed consent.

Exclusion criteria

✕. 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.
✕. Pregnant and lactating women, or those planning a pregnancy over the course of the study
✕. Uncontrolled systemic disease
✕. Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

What they're measuring

ocular surface disease index (OSDI)

Timeframe: baseline

numerical rating scale (NRS)

Timeframe: baseline

NPSI-Eye (range 0-100 score)

Timeframe: baseline

Tear break-up time (TBUT)(s)

Timeframe: baseline

Corneal fluorescein staining (CFS)

Timeframe: baseline

Trial details

NCT IDNCT05600985

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-18

Contact for this trial

Lu Zhao, M.D.

19801152870 Drzl1996@163.com

View on ClinicalTrials.gov More Dry Eye trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18years to 40 years
✓. Male or female
✓. DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without FS-LASIK
✓. Provision of written informed consent.

Exclusion criteria

✕. 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.
✕. Pregnant and lactating women, or those planning a pregnancy over the course of the study
✕. Uncontrolled systemic disease
✕. Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.