Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

NCT05600985 | Unknown

• 1 other identifier: DED-RS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (5)

• ocular surface disease index (OSDI)

  OSDI is one of the most frequently used questionnaires for evaluation of dry eye . This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.

  baseline

• 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.

  baseline

• 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)

  baseline

• Tear break-up time (TBUT)(s)

  BUT is the time from normal blinking to the first appearance of a break in the tear film.

  baseline

• 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.

  baseline

Secondary Outcomes (21)

• the concentration of Interleukin-1β（IL-1β) (pg/ml)

  baseline

• the concentration of Interleukin-6 (IL-6) (pg/ml)

  baseline

• the concentration of Interleukin-10 (IL-10) (pg/ml)

  baseline

• the concentration of Interleukin-23 (IL-23) (pg/ml)

  baseline

• the concentration of Interleukin-17A (IL-17A) (pg/ml)

  baseline

Study Arms (3)

DED after FS-LASIK

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

Procedure: FS-LASIK

DED without FS-LASIK

patients with dry eye who did not have refractive surgery

normal control

subjects with no ocular symptoms and no previous ocular surgeries

Interventions

FS-LASIK PROCEDURE

Laser-assisted in situ keratomileusis, commonly referred to laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia, hypermetropia, and astigmatism.

Also known as: Femtosecond laser-assisted in situ keratomileusis

DED after FS-LASIK

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients from Peking University Third Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Zhao L, Zhou Y, Duan H, Zhang Y, Ma B, Yang T, Chen J, Chen Y, Qi H. Analysis of Clinical Characteristics and Neuropeptides in Patients with Dry Eye with and without Chronic Ocular Pain after FS-LASIK. Ophthalmol Ther. 2024 Mar;13(3):711-723. doi: 10.1007/s40123-023-00861-3. Epub 2024 Jan 8.

  PMID: 38190027 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

basal tears

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Hong Qi, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Lu Zhao, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Zhao, M.D.

CONTACT

19801152870; Drzl1996@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: October 29, 2022
• Primary Completion: September 18, 2023
• Study Completion: September 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)