Dry EyeNCT05600985
Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery
An observational study of Dry Eye, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- FS-LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients from Peking University Third Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hong Qi, MD, doctorqihong@163.com
About this study
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- FS-LASIK
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS-LASIKProcedure or surgery
Also called Femtosecond laser-assisted in situ keratomileusis
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.
| Study group | Role | What they receive |
|---|---|---|
| DED after FS-LASIK | patients with dry eye disease (DED) after refractive surgery (RS） Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (21)
the concentration of Interleukin-1β（IL-1β) (pg/ml)
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
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.
Measured: baseline
the concentration of interferon-γ (IFN-γ)(pg/ml)
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
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
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.
Measured: baseline
the concentration of β-endorphin (pg/ml)
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Schirmer Ⅰ test (SⅠt) (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.
Measured: baseline
tear meniscus height (TMH)(mm)
The amounts of basal tears between the upper and lower eyelid margin.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
sub-basal corneal nerve density (mm/mm2)
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.
Measured: baseline
Hamilton anxiety scale
to evaluate the psychological status of patients. A total score of less than 7 indicates normal.
Measured: baseline
Hamilton Depression scale
to evaluate the psychological status of patients. A total score of less than 7 indicates normal.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start29 Oct 2022
- Primary completion18 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, M.D., Principal investigator, Peking University Third HospitalLu Zhao, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600985
- Sponsor's protocol ID
- DED-RS
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38190027
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery
- ClinicalTrials.gov ID
- NCT05600985
- Acronym / sponsor ID
- DED-RS
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 18 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DED after FS-LASIK | – | Procedure: FS-LASIKpatients with dry eye disease (DED) after refractive surgery (RS） |
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients from Peking University Third Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS-LASIKAlso: Femtosecond laser-assisted in situ keratomileusisLaser-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. | Procedure or surgery | DED after FS-LASIK |
Primary outcome
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.
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.
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)
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.
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.
21 secondary outcomes
the concentration of Interleukin-1β（IL-1β) (pg/ml)
Time frame: baseline
the concentration of Interleukin-6 (IL-6) (pg/ml)
Time frame: baseline
the concentration of Interleukin-10 (IL-10) (pg/ml)
Time frame: baseline
the concentration of Interleukin-23 (IL-23) (pg/ml)
Time frame: baseline
the concentration of Interleukin-17A (IL-17A) (pg/ml)
Time frame: baseline
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
Time frame: baseline
the concentration of interferon-γ (IFN-γ)(pg/ml)
Time frame: baseline
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
Time frame: baseline
the concentration of substance P (SP)(pg/ml)
Time frame: baseline
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
Time frame: baseline
the concentration of β-endorphin (pg/ml)
Time frame: baseline
the concentration of neurotensin(pg/ml)
Time frame: baseline
the concentration of oxytocin(pg/ml)
Time frame: baseline
Schirmer Ⅰ test (SⅠt) (mm/5 minutes)
Time frame: baseline
tear meniscus height (TMH)(mm)
Time frame: baseline
Lissamine green staining
Time frame: baseline
meibomian gland dropout rate
Time frame: baseline
corneal sensitivity (range, 60-0 mm)
Time frame: baseline
sub-basal corneal nerve density (mm/mm2)
Time frame: baseline
Hamilton anxiety scale
Time frame: baseline
Hamilton Depression scale
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 38190027Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Qi, M.D. principal investigator
Peking University Third Hospital
Lu Zhao, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Zhao, M.D. (19801152870 ext. 010, Drzl1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular surface disease index (OSDI) (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.