CorneaNCT04899258
Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study
A study testing Femtosecond laser assisted LASIK in people with Cornea and Refractive Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea, Refractive Surgery, Anterior Chamber Inflammation
- What is being tested?
- Femtosecond laser assisted LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2019to 15 Jul 2020
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.
- Uncomplicated surgery
Who cannot join
- Complicated surgery,
- Hyperopic or hyperopic astigmatism
- Lack of follow-up measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells
This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.
Read the detailed description
Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to determine the direct and indirect effects of these applications on the corneal endothelium, the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not been previously investigated. Therefore, we evaluated these effects using objective measurement methods, such as specular microscopy and laser flare photometry.
- Conditions
- Cornea, Refractive Surgery, Anterior Chamber Inflammation
- Being tested
- Femtosecond laser assisted LASIK
- Keywords
- Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser assisted LASIKProcedure or surgery
Refractive surgery
| Study group | Role | What they receive |
|---|---|---|
| Pre-surgery and post-surgery | Other | femtosecond assisted LASIK Receives: Procedure: Femtosecond laser assisted LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Flare Values
To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry
Measured: The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values
Secondary outcomes (1)
Change of Corneal endothelium features-1
Endothelial cell density (ECD),(The parameter was measured by specular microscopy)
Measured: the changes of the parameters of preoperative and 3. months' values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start12 Dec 2019
- Primary completion14 Mar 2020
- Study completion15 Jul 2020
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 CorneaStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, before-after study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Turgay Ozbilen, Istanbul University
- Investigators
- Kemal Turgay Ozbilen, M.D., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899258
- Sponsor's protocol ID
- 06.12.2019/20/1495
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozbilen KT, Altinkurt E, Ceylan NA, Bilgin GS, Gozum N. Effect of Myopic Femtosecond Laser-Assisted LASIK on Anterior Chamber Inflammation (Flare Values) and Corneal Endothelium: A Prospective before and after Study. J Ophthalmol. 2021 Nov 26;2021:2395028. doi: 10.1155/2021/2395028. eCollection 2021.
PubMed 34868671
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells
- ClinicalTrials.gov ID
- NCT04899258
- Acronym / sponsor ID
- 06.12.2019/20/1495
- Conditions
- Cornea, Refractive Surgery, Anterior Chamber Inflammation
- Keywords
- Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 24 May 2021 (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.
This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.
Detailed description
Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to determine the direct and indirect effects of these applications on the corneal endothelium, the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not been previously investigated. Therefore, we evaluated these effects using objective measurement methods, such as specular microscopy and laser flare photometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, before-after study
| Arm | Type | Receives |
|---|---|---|
| Pre-surgery and post-surgery | Other | Procedure: Femtosecond laser assisted LASIKfemtosecond assisted LASIK |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.
- Uncomplicated surgery
Key exclusion criteria (3 listed)
- Complicated surgery,
- Hyperopic or hyperopic astigmatism
- Lack of follow-up measurements
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 |
|---|---|---|
| Femtosecond laser assisted LASIKRefractive surgery | Procedure or surgery | Pre-surgery and post-surgery |
Primary outcome
Change of Flare Values
Time frame: The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values
To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry
1 secondary outcome
Change of Corneal endothelium features-1
Time frame: the changes of the parameters of preoperative and 3. months' values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 34868671Ozbilen KT, Altinkurt E, Ceylan NA, Bilgin GS, Gozum N. Effect of Myopic Femtosecond Laser-Assisted LASIK on Anterior Chamber Inflammation (Flare Values) and Corneal Endothelium: A Prospective before and after Study. J Ophthalmol. 2021 Nov 26;2021:2395028. doi: 10.1155/2021/2395028. eCollection 2021.
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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.
Kemal Turgay Ozbilen, M.D. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond laser assisted LASIK in people with Cornea and Refractive Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Flare Values (time frame: The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values). 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 NCT04899258, 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 24 May 2021.