Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

June 20, 2023 updated by: Peking University Third Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients from Peking University Third Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DED after FS-LASIK
patients with dry eye disease (DED) after refractive surgery (RS）
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.
Other Names:
  • Femtosecond laser-assisted in situ keratomileusis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ocular surface disease index (OSDI)
Time Frame: baseline

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
Tear break-up time (TBUT)(s)
Time Frame: baseline
BUT is the time from normal blinking to the first appearance of a break in the tear film.
baseline
Corneal fluorescein staining (CFS)
Time Frame: baseline
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
numerical rating scale (NRS)
Time Frame: baseline
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)
Time Frame: baseline
Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Hong Qi, M.D., Peking University Third Hospital
  • Principal Investigator: Lu Zhao, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2022

Primary Completion (Estimated)

September 18, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 29, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DED-RS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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