Refractive SurgeryNCT06448468
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
An observational study of Refractive Surgery, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
By using 16S rRNA sequencing technology to analyze the changes in ocular surface microbiota before and after surgery, as well as the impact of changes in ocular surface microbiota on FS-LASIK induced DES, new treatment ideas are provided for corneal FS-LASIK induced DES patients, and the incidence of FS-LASIK related… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Nov 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dry eye patients after FS-LASIK
Who may be able to join
- Age ≥ 18 years old;
- Stable refractive index (refractive index change less than 0.5D in the past 2 years);
- The best corrected far vision (CDVA) is 1.0 or better;
- Postoperative dry eye patients need to meet the following criteria: Patient's Eye Surface Disease Index (OSDI) ≥ 13 and two of the following three criteria are met: Tear film rupture time (BUT) ≤ 10S Schirmer I test (mm/5min) ≤ 10mm, corneal fluorescein sodium staining exceeding 5 spots;
Who cannot join
- History of eye trauma or surgery;
- Suspected keratoconus;
- Previously suffering from other eye diseases such as keratitis or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, amblyopia, etc.;
- Preoperative history of severe dry eye disease;
- Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; Or severe mental disorders, such as anxiety and depression;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yifeng Yu
Nanchang, Jiangxi, 330008
yifeng yu, +8613979180258, 171018170@qq.com
About this study
By using 16S rRNA sequencing technology to analyze the changes in ocular surface microbiota before and after surgery, as well as the impact of changes in ocular surface microbiota on FS-LASIK induced DES, new treatment ideas are provided for corneal FS-LASIK induced DES patients, and the incidence of FS-LASIK related DES is reduced.
Read the detailed description
This study aims to include 160 postoperative patients, who will be divided into a dry eye group and a normal group based on postoperative dry eye examination. Microbial samples of the patient's conjunctival sac will be collected, and changes in the ocular surface microbiota before and after surgery will be analyzed using 16S rRNA sequencing technology. The impact of changes in the ocular surface microbiota on FS-LASIK induced DES will also be analyzed, providing new treatment ideas for FS-LASIK induced DES patients and reducing the incidence of FS-LASIK related DES.
- Conditions
- Refractive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dry group | Not described | |
| Non dry eye group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sampling of conjunctival sac microbiota
Microbial diversity of conjunctival sac
Measured: Preoperative and Postoperative DAY 90
Dry eye examination
Tear Film Break Up Time
Measured: Preoperative and Postoperative DAY 90
Corneal nerve condition
corneal nerve fiber density
Measured: Preoperative and Postoperative DAY 90
Dry eye examination
Schirmer Ⅰ test
Measured: Preoperative and Postoperative DAY 90
Dry eye examination
ocular surface disease index
Measured: Preoperative and Postoperative DAY 90
Corneal nerve condition
corneal nerve branch density
Measured: Preoperative and Postoperative DAY 90
Corneal nerve condition
corneal nerve fibre length
Measured: Preoperative and Postoperative DAY 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 May 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (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 Refractive SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448468
- Sponsor's protocol ID
- [2024] No. (34).
- Status last verified
- Jul 2024
- First submitted
- 27 May 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu J, Cheng C, Yu K, Wang Q, Peng Y, Li Y, Yao W, Pi Y, Yu S, Han Z, Wei J, Chen T, Yu Y. Ocular Surface Microbiota Alterations Following FS-LASIK and Their Association With Postoperative Dry Eye. Can J Infect Dis Med Microbiol. 2026 Mar 4;2026:2148587. doi: 10.1155/cjid/2148587. eCollection 2026.
PubMed 41788695
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)
- ClinicalTrials.gov ID
- NCT06448468
- Acronym / sponsor ID
- [2024] No. (34).
- Conditions
- Refractive Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 7 Jun 2024 (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.
By using 16S rRNA sequencing technology to analyze the changes in ocular surface microbiota before and after surgery, as well as the impact of changes in ocular surface microbiota on FS-LASIK induced DES, new treatment ideas are provided for corneal FS-LASIK induced DES patients, and the incidence of FS-LASIK related DES is reduced.
Detailed description
This study aims to include 160 postoperative patients, who will be divided into a dry eye group and a normal group based on postoperative dry eye examination. Microbial samples of the patient's conjunctival sac will be collected, and changes in the ocular surface microbiota before and after surgery will be analyzed using 16S rRNA sequencing technology. The impact of changes in the ocular surface microbiota on FS-LASIK induced DES will also be analyzed, providing new treatment ideas for FS-LASIK induced DES patients and reducing the incidence of FS-LASIK related DES.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry group | – | – |
| Non dry eye group | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dry eye patients after FS-LASIK
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- Stable refractive index (refractive index change less than 0.5D in the past 2 years);
- The best corrected far vision (CDVA) is 1.0 or better;
- Postoperative dry eye patients need to meet the following criteria: Patient's Eye Surface Disease Index (OSDI) ≥ 13 and two of the following three criteria are met: Tear film rupture time (BUT) ≤ 10S Schirmer I test (mm/5min) ≤ 10mm, corneal fluorescein sodium staining exceeding 5 spots;
Key exclusion criteria (5 listed)
- History of eye trauma or surgery;
- Suspected keratoconus;
- Previously suffering from other eye diseases such as keratitis or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, amblyopia, etc.;
- Preoperative history of severe dry eye disease;
- Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; Or severe mental disorders, such as anxiety and depression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sampling of conjunctival sac microbiota
Time frame: Preoperative and Postoperative DAY 90
Microbial diversity of conjunctival sac
Dry eye examination
Time frame: Preoperative and Postoperative DAY 90
Tear Film Break Up Time
Corneal nerve condition
Time frame: Preoperative and Postoperative DAY 90
corneal nerve fiber density
Dry eye examination
Time frame: Preoperative and Postoperative DAY 90
Schirmer Ⅰ test
Dry eye examination
Time frame: Preoperative and Postoperative DAY 90
ocular surface disease index
Corneal nerve condition
Time frame: Preoperative and Postoperative DAY 90
corneal nerve branch density
Corneal nerve condition
Time frame: Preoperative and Postoperative DAY 90
corneal nerve fibre length
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 41788695Xu J, Cheng C, Yu K, Wang Q, Peng Y, Li Y, Yao W, Pi Y, Yu S, Han Z, Wei J, Chen T, Yu Y. Ocular Surface Microbiota Alterations Following FS-LASIK and Their Association With Postoperative Dry Eye. Can J Infect Dis Med Microbiol. 2026 Mar 4;2026:2148587. doi: 10.1155/cjid/2148587. eCollection 2026.
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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.
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 Refractive Surgery, run by Second Affiliated Hospital of Nanchang University 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 5 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 31 Jul 2024. 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 yifeng yu (13979180258, 171018170@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sampling of conjunctival sac microbiota (time frame: Preoperative and Postoperative DAY 90). The study lists 7 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 NCT06448468, 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 31 Jul 2024.