Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

Dry Eye Clinical Trial

Official title:

Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600985
• Other study ID #: DED-RS
• Status: Recruiting
• Start date: October 29, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Peking University Third Hospital
• Contact: Lu Zhao, M.D.
• Phone: 19801152870
• Email: Drzl1996[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• FS-LASIK
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	the concentration of Interleukin-1ß(IL-1ß) (pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-1ß levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of Interleukin-6 (IL-6) (pg/ml)	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.	baseline
Secondary	the concentration of Interleukin-10 (IL-10) (pg/ml)	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.	baseline
Secondary	the concentration of Interleukin-23 (IL-23) (pg/ml)	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.	baseline
Secondary	the concentration of Interleukin-17A (IL-17A) (pg/ml)	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.	baseline
Secondary	the concentration of tumor necrosis factor-a (TNF-a)(pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. TNF-a levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of interferon-? (IFN-?)(pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IFN-? levels will be quantified by Luminex immunoassay	baseline
Secondary	the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)	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.	baseline
Secondary	the concentration of substance P (SP)(pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of alpha-melanocyte-stimulating hormone (a-MSH) (pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. a-MSH levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of ß-endorphin (pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. ß-endorphin levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of neurotensin(pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. neurotensin levels will be quantified by Luminex immunoassay.	baseline
Secondary	the concentration of oxytocin(pg/ml)	basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay.	baseline
Secondary	Schirmer ? test (S?t) (mm/5 minutes)	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.	baseline
Secondary	tear meniscus height (TMH)(mm)	The amounts of basal tears between the upper and lower eyelid margin.	baseline
Secondary	Lissamine green staining	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.	baseline
Secondary	meibomian gland dropout rate	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.	baseline
Secondary	corneal sensitivity (range, 60-0 mm)	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.	baseline
Secondary	sub-basal corneal nerve density (mm/mm2)	Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.	baseline
Secondary	Hamilton anxiety scale	to evaluate the psychological status of patients. A total score of less than 7 indicates normal.	baseline
Secondary	Hamilton Depression scale	to evaluate the psychological status of patients. A total score of less than 7 indicates normal.	baseline