MyopiaNCT02551796
Early Changes Among FLEx, LASIK and FS-LASIK
A study testing lenticule extraction, laser in situ keratomileusis and FS assisted laser in situ keratomileusis in people with Myopia and Astigmatism, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures. Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- lenticule extraction, laser in situ keratomileusis and FS assisted laser in situ keratomileusis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Apr 2016
- 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 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- minimum age of 18 years(range from 18 year to 31 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between
- 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 42.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery
Who cannot join
- systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year
Trial locations and contacts
1 site in 1 country.
China1 site
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
Haikou, Hainan, 570311
About this study
Official title: Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis
To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.
Read the detailed description
Laser in situ keratomileusis (LASIK) with a microkeratome has been accepted wildly in the past 20 years. Gradually, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.
Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.
This prospective clinical study is going to analyze the short-term changes in ocular surface measures and tear inflammatory mediators after FLEx, LASIK and FS-LASIK procedures.
- Conditions
- Myopia, Astigmatism
- Being tested
- lenticule extraction, laser in situ keratomileusis, FS assisted laser in situ keratomileusis
- Keywords
- lenticule extraction, laser in situ keratomileusis, femtosecond laser-assisted laser in situ keratomileusis, tear, inflammatory mediators
- Medical subject headings
- Myopia, Astigmatism, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenticule extractionProcedure or surgery
Also called 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
Four femtosecond incisions will be created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction is released, the flap will be opened using a thin, blunt spatula and the free refractive lenticule will be subsequently grasped with a forceps and extracted, after which the flap will be repositioned carefully.
laser in situ keratomileusisProcedure or surgery
Also called 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
During LASIK surgery, the eye will be gently proptosed and a hinged corneal flap will be cut using a microkeratome. The flap will be lifted and the stromal bed will receive a 6 mm diameter and stroma ablation. Finally reposition the flap carefully.
FS assisted laser in situ keratomileusisProcedure or surgery
Also called 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
Track distance and spot distance will be 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter will be 8.0 mm, and flap thickness will be set to 105 μm. Side-cut angle and hinge angle will be 90°and 50° respectively. The flaps will be created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system will be used in the subsequent ablation of thstromal bed with a 6.0 mm optical zone. Once the excimer. ablation is completed, the flap will be repositioned in a similar fashion as in routine LASIK.
| Study group | Role | What they receive |
|---|---|---|
| lenticule extraction | Experimental | The patients in this group chose to receive the lenticule extraction surgery. Receives: Procedure: lenticule extraction |
| laser in situ keratomileusis | Experimental | The patients in this group chose to receive the laser in situ keratomileusis surgery. Receives: Procedure: laser in situ keratomileusis |
| FS assisted laser in situ keratomileusis | Experimental | The patients in this group chose to receive the FS assisted laser in situ keratomileusis surgery. Receives: Procedure: FS assisted laser in situ keratomileusis |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of Schirmer I test
Measured: up to 1month after surgery
scale of corneal fluorescein staining
Measured: up to 1month after surgery
scale of noninvasive tear breakup time
Measured: up to 1month after surgery
questionnaire of ocular surface disease index
Measured: up to 1month after surgery
scale of central corneal sensitivity
Measured: up to 1month after surgery
scale of tear meniscus height
Measured: up to 1month after surgery
concentration of Interleukin-1α
Measured: up to 1month after surgery
concentration of tumor necrosis factor-α
Measured: up to 1month after surgery
concentration of nerve growth factor
Measured: up to 1month after surgery
interferon-γ
Measured: up to 1month after surgery
concentration of transforming growth factor-β1
Measured: up to 1month after surgery
concentration of matrix metalloproteinase-9
Measured: up to 1month after surgery
Secondary outcomes (12)
Correlation between Interleukin-1α and ocular surface disease index
Measured: up to 1month after surgery
Correlation between tumor necrosis factor-α and ocular surface disease index
Measured: up to 1month after surgery
Correlation between nerve growth factor and ocular surface disease index
Measured: up to 1month after surgery
Correlation between interferon-γ and ocular surface disease index
Measured: up to 1month after surgery
Correlation between transforming growth factor-β1 and ocular surface disease index
Measured: up to 1month after surgery
Correlation between matrix metalloproteinase-9 and ocular surface disease index
Measured: up to 1month after surgery
Correlation between Interleukin-1α and corneal fluorescein staining
Measured: up to 1month after surgery
Correlation between tumor necrosis factor-α and corneal fluorescein staining
Measured: up to 1month after surgery
Correlation between nerve growth factor and corneal fluorescein staining
Measured: up to 1month after surgery
Correlation between interferon-γ and corneal fluorescein staining
Measured: up to 1month after surgery
Correlation between transforming growth factor-β1 and corneal fluorescein staining
Measured: up to 1month after surgery
Correlation between matrix metalloproteinase-9 and corneal fluorescein staining
Measured: up to 1month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingwu Zhong, MD PhD, Sun Yat-sen University
- Investigators
- Xingwu Zhong, Principal investigator, Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551796
- Sponsor's protocol ID
- 2015-001
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis
- ClinicalTrials.gov ID
- NCT02551796
- Acronym / sponsor ID
- 2015-001
- Conditions
- Myopia, Astigmatism
- Keywords
- lenticule extraction, laser in situ keratomileusis, femtosecond laser-assisted laser in situ keratomileusis, tear, inflammatory mediators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.
Detailed description
Laser in situ keratomileusis (LASIK) with a microkeratome has been accepted wildly in the past 20 years. Gradually, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.
Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.
This prospective clinical study is going to analyze the short-term changes in ocular surface measures and tear inflammatory mediators after FLEx, LASIK and FS-LASIK procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lenticule extraction | Experimental | Procedure: lenticule extractionThe patients in this group chose to receive the lenticule extraction surgery. |
| laser in situ keratomileusis | Experimental | Procedure: laser in situ keratomileusisThe patients in this group chose to receive the laser in situ keratomileusis surgery. |
| FS assisted laser in situ keratomileusis | Experimental | Procedure: FS assisted laser in situ keratomileusisThe patients in this group chose to receive the FS assisted laser in situ keratomileusis surgery. |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- minimum age of 18 years(range from 18 year to 31 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between
- 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 42.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery
Key exclusion criteria (1 listed)
- systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year
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 |
|---|---|---|
| lenticule extractionAlso: 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)Four femtosecond incisions will be created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction is released, the flap will be opened using a thin, blunt spatula and the free refractive lenticule will be subsequently grasped with a forceps and extracted, after which the flap will be repositioned carefully. | Procedure or surgery | lenticule extraction |
| laser in situ keratomileusisAlso: 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)During LASIK surgery, the eye will be gently proptosed and a hinged corneal flap will be cut using a microkeratome. The flap will be lifted and the stromal bed will receive a 6 mm diameter and stroma ablation. Finally reposition the flap carefully. | Procedure or surgery | laser in situ keratomileusis |
| FS assisted laser in situ keratomileusisAlso: 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)Track distance and spot distance will be 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter will be 8.0 mm, and flap thickness will be set to 105 μm. Side-cut angle and hinge angle will be 90°and 50° respectively. The flaps will be created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system will be used in the subsequent ablation of thstromal bed with a 6.0 mm optical zone. Once the excimer. ablation is completed, the flap will be repositioned in a similar fashion as in routine LASIK. | Procedure or surgery | FS assisted laser in situ keratomileusis |
Primary outcome
scale of Schirmer I test
Time frame: up to 1month after surgery
scale of corneal fluorescein staining
Time frame: up to 1month after surgery
scale of noninvasive tear breakup time
Time frame: up to 1month after surgery
questionnaire of ocular surface disease index
Time frame: up to 1month after surgery
scale of central corneal sensitivity
Time frame: up to 1month after surgery
scale of tear meniscus height
Time frame: up to 1month after surgery
concentration of Interleukin-1α
Time frame: up to 1month after surgery
concentration of tumor necrosis factor-α
Time frame: up to 1month after surgery
concentration of nerve growth factor
Time frame: up to 1month after surgery
interferon-γ
Time frame: up to 1month after surgery
concentration of transforming growth factor-β1
Time frame: up to 1month after surgery
concentration of matrix metalloproteinase-9
Time frame: up to 1month after surgery
12 secondary outcomes
Correlation between Interleukin-1α and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between tumor necrosis factor-α and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between nerve growth factor and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between interferon-γ and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between transforming growth factor-β1 and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between matrix metalloproteinase-9 and ocular surface disease index
Time frame: up to 1month after surgery
Correlation between Interleukin-1α and corneal fluorescein staining
Time frame: up to 1month after surgery
Correlation between tumor necrosis factor-α and corneal fluorescein staining
Time frame: up to 1month after surgery
Correlation between nerve growth factor and corneal fluorescein staining
Time frame: up to 1month after surgery
Correlation between interferon-γ and corneal fluorescein staining
Time frame: up to 1month after surgery
Correlation between transforming growth factor-β1 and corneal fluorescein staining
Time frame: up to 1month after surgery
Correlation between matrix metalloproteinase-9 and corneal fluorescein staining
Time frame: up to 1month after surgery
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 14 Jun 2016.
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
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.
Xingwu Zhong principal investigator
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen 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 lenticule extraction, laser in situ keratomileusis and FS assisted laser in situ keratomileusis in people with Myopia and Astigmatism, run by Sun Yat-sen 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 2 inclusion and 1 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 14 Jun 2016. 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?
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?
scale of Schirmer I test (time frame: up to 1month after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2016.