Myopic AstigmatismNCT03947944
Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Using Vector Planning Method.
A study testing SMILE using manifest refraction planning and SMILE using vector planning in people with Myopic Astigmatism, run by Yonsei University at 1 site in South Korea.
Trial summary
In the past two decades, the femtosecond laser (FSL) technology has been introduced in the corneal refractive surgery filed, and brought a remarkable innovation. It can make tissue dissection through photodisruption and plasma cavitation. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Myopic Astigmatism
- What is being tested?
- SMILE using manifest refraction planning and SMILE using vector planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2018to 7 May 2019
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age of 20 years or older.
- 2. Myopia
- 3. Who is willing to get SMILE surgery
Who cannot join
- 1. Severe ocular surface disease
- 2. Any corneal disease, cataract, glaucoma, macular disease, or previous history of intraocular or corneal surgery
- 3. Patients with suspicion of keratoconus on corneal topography
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, 03722
About this study
In the past two decades, the femtosecond laser (FSL) technology has been introduced in the corneal refractive surgery filed, and brought a remarkable innovation. It can make tissue dissection through photodisruption and plasma cavitation. Initially, the FSL was used predominantly to make a corneal flap when performing laser in situ keratomileusis (LASIK), which is followed by stromal ablation using excimer laser. A new surgical technique called femtosecond lenticule extraction (FLEx) has been developed that uses only FSL to dissect two interfaces to create refractive lenticule and then remove it, which is very similar with LASIK. Small incision lenticule extraction (SMILE) which is the advanced form of all-in-one FSL refractive technique does not make a corneal flap rather make small incision where the separated refractive lenticule is removed through, and the upper part of the corneal tissue is called cap. Since the clinical outcomes of SMILE were firstly published in 2011, SMILE has been widely used for correction of myopia or myopic astigmatism worldwide. SMILE provides excellent visual outcomes and has advantages including a lesser decrease in corneal sensitivity and absence of flap related complications compared to LASIK.
The vector planning method is newly developed astigmatism correction method, which combines refraction astigmatism in 60 % emphasis and corneal astigmatism in 40 % emphasis. The vectorial difference between corneal astigmatism and refractive cylinder at the corneal plane is ocular residual astigmatism (ORA). In normal eyes treated for myopic astigmatism, the ORA typically ranges from 0.73 to 0.81 D. The eyes with high ORA resulted in inferior clinical outcomes after corneal refractive surgery including LASIK, LASEK, and SMILE. The vector planning method was effective in LASIK according to previous study. Therefore we try to confirm the efficacy of vector planning method in SMILE.
Read the detailed description
Enrollment period : 6 months after IRB approval Participants : The subjects over 20 years old, who visited Severance hospital and Eyereum eye clinic for SMILE surgery with myopic astigmatism. The participants who satisfies criteria, and who can be monitored at all times during each period of observation after surgery are included in the study.
Methods: The subjects are randomly divided into two groups. One group underwent SMILE surgery using manifest refraction based planning, and the other group underwent SMILE surgery using vector planning. Before surgery, all patients underwent a detailed ophthalmological examination that included evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected-distance visual acuity (UDVA) and CDVA, manifest refraction, slit-lamp examination (Haag-Streit, Köniz, Switzerland), keratometry, and Scheimpflug-based corneal topography (Pentacam HR, Oculus). Dynamic corneal response (DCR) parameters were examined using Corvis ST. Corneal wavefront aberrations were measured using Keratron Scout (Optikon 2000, Rome, Italy). All examinations were repeated at 1, 3, and 6 months after surgery.
- Conditions
- Myopic Astigmatism
- Being tested
- SMILE using manifest refraction planning, SMILE using vector planning
- Keywords
- Small incision lenticule extraction, astigmatism, vector planning
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILE using manifest refraction planningProcedure or surgery
The treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis.
SMILE using vector planningProcedure or surgery
The treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis.
| Study group | Role | What they receive |
|---|---|---|
| manifest refraction planning group | Active comparator | The subjects underwent SMILE using manifest refraction planning. Receives: Procedure: SMILE using manifest refraction planning |
| vector planning group | Active comparator | The subjects underwent SMILE using vector planning. Receives: Procedure: SMILE using vector planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Vision Acuity at each time point between the two groups.
Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Measured: preoperative
Uncorrected Distance Vision Acuity at each time point between the two groups.
Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Measured: postoperative 6 months
Corrected Distance vision Acuity at each time point between the two groups.
Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Measured: preoperative
Corrected Distance vision Acuity at each time point between the two groups.
Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Measured: postoperative 6 months
Secondary outcomes (24)
Total higher order aberration at each time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Total higher order aberration at each time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Total higher order aberration at each time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Total higher order aberration at each time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".
- Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Spherical aberration at each time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Spherical aberration at each time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Spherical aberration at each time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Spherical aberration at each time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Spherical aberration changes from baseline at each postoperative time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Spherical aberration changes from baseline at each postoperative time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Spherical aberration changes from baseline at each postoperative time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Spherical aberration changes from baseline at each postoperative time point between the two groups.
- Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Coma aberration at each time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Coma aberration at each time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Coma aberration at each time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Coma aberration at each time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Coma aberration changes from baseline at each postoperative time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: preoperative
Coma aberration changes from baseline at each postoperative time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: postoperative 1 month
Coma aberration changes from baseline at each postoperative time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 3 months
Coma aberration changes from baseline at each postoperative time point between the two groups.
- Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start16 Aug 2018
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic AstigmatismStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947944
- Sponsor's protocol ID
- 1-2018-0038
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Using Vector Planning Method.
- ClinicalTrials.gov ID
- NCT03947944
- Acronym / sponsor ID
- 1-2018-0038
- Conditions
- Myopic Astigmatism
- Keywords
- Small incision lenticule extraction, astigmatism, vector planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 13 May 2019 (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 the past two decades, the femtosecond laser (FSL) technology has been introduced in the corneal refractive surgery filed, and brought a remarkable innovation. It can make tissue dissection through photodisruption and plasma cavitation. Initially, the FSL was used predominantly to make a corneal flap when performing laser in situ keratomileusis (LASIK), which is followed by stromal ablation using excimer laser. A new surgical technique called femtosecond lenticule extraction (FLEx) has been developed that uses only FSL to dissect two interfaces to create refractive lenticule and then remove it, which is very similar with LASIK. Small incision lenticule extraction (SMILE) which is the advanced form of all-in-one FSL refractive technique does not make a corneal flap rather make small incision where the separated refractive lenticule is removed through, and the upper part of the corneal tissue is called cap. Since the clinical outcomes of SMILE were firstly published in 2011, SMILE has been widely used for correction of myopia or myopic astigmatism worldwide. SMILE provides excellent visual outcomes and has advantages including a lesser decrease in corneal sensitivity and absence of flap related complications compared to LASIK.
The vector planning method is newly developed astigmatism correction method, which combines refraction astigmatism in 60 % emphasis and corneal astigmatism in 40 % emphasis. The vectorial difference between corneal astigmatism and refractive cylinder at the corneal plane is ocular residual astigmatism (ORA). In normal eyes treated for myopic astigmatism, the ORA typically ranges from 0.73 to 0.81 D. The eyes with high ORA resulted in inferior clinical outcomes after corneal refractive surgery including LASIK, LASEK, and SMILE. The vector planning method was effective in LASIK according to previous study. Therefore we try to confirm the efficacy of vector planning method in SMILE.
Detailed description
Enrollment period : 6 months after IRB approval Participants : The subjects over 20 years old, who visited Severance hospital and Eyereum eye clinic for SMILE surgery with myopic astigmatism. The participants who satisfies criteria, and who can be monitored at all times during each period of observation after surgery are included in the study.
Methods: The subjects are randomly divided into two groups. One group underwent SMILE surgery using manifest refraction based planning, and the other group underwent SMILE surgery using vector planning. Before surgery, all patients underwent a detailed ophthalmological examination that included evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected-distance visual acuity (UDVA) and CDVA, manifest refraction, slit-lamp examination (Haag-Streit, Köniz, Switzerland), keratometry, and Scheimpflug-based corneal topography (Pentacam HR, Oculus). Dynamic corneal response (DCR) parameters were examined using Corvis ST. Corneal wavefront aberrations were measured using Keratron Scout (Optikon 2000, Rome, Italy). All examinations were repeated at 1, 3, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manifest refraction planning group | Active comparator | Procedure: SMILE using manifest refraction planningThe subjects underwent SMILE using manifest refraction planning. |
| vector planning group | Active comparator | Procedure: SMILE using vector planningThe subjects underwent SMILE using vector planning. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Age of 20 years or older.
- 2. Myopia
- 3. Who is willing to get SMILE surgery
Key exclusion criteria (3 listed)
- 1. Severe ocular surface disease
- 2. Any corneal disease, cataract, glaucoma, macular disease, or previous history of intraocular or corneal surgery
- 3. Patients with suspicion of keratoconus on corneal topography
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 |
|---|---|---|
| SMILE using manifest refraction planningThe treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis. | Procedure or surgery | manifest refraction planning group |
| SMILE using vector planningThe treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis. | Procedure or surgery | vector planning group |
Primary outcome
Uncorrected Distance Vision Acuity at each time point between the two groups.
Time frame: preoperative
Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Uncorrected Distance Vision Acuity at each time point between the two groups.
Time frame: postoperative 6 months
Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Corrected Distance vision Acuity at each time point between the two groups.
Time frame: preoperative
Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
Corrected Distance vision Acuity at each time point between the two groups.
Time frame: postoperative 6 months
Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.
24 secondary outcomes
Total higher order aberration at each time point between the two groups.
Time frame: preoperative
Total higher order aberration at each time point between the two groups.
Time frame: postoperative 1 month
Total higher order aberration at each time point between the two groups.
Time frame: 3 months
Total higher order aberration at each time point between the two groups.
Time frame: 6 months
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Time frame: preoperative
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Time frame: postoperative 1 month
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 3 months
Total higher order aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 6 months
Spherical aberration at each time point between the two groups.
Time frame: preoperative
Spherical aberration at each time point between the two groups.
Time frame: postoperative 1 month
Spherical aberration at each time point between the two groups.
Time frame: 3 months
Spherical aberration at each time point between the two groups.
Time frame: 6 months
Spherical aberration changes from baseline at each postoperative time point between the two groups.
Time frame: preoperative
Spherical aberration changes from baseline at each postoperative time point between the two groups.
Time frame: postoperative 1 month
Spherical aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 3 months
Spherical aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 6 months
Coma aberration at each time point between the two groups.
Time frame: preoperative
Coma aberration at each time point between the two groups.
Time frame: postoperative 1 month
Coma aberration at each time point between the two groups.
Time frame: 3 months
Coma aberration at each time point between the two groups.
Time frame: 6 months
Coma aberration changes from baseline at each postoperative time point between the two groups.
Time frame: preoperative
Coma aberration changes from baseline at each postoperative time point between the two groups.
Time frame: postoperative 1 month
Coma aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 3 months
Coma aberration changes from baseline at each postoperative time point between the two groups.
Time frame: 6 months
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 13 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMILE using manifest refraction planning and SMILE using vector planning in people with Myopic Astigmatism, run by Yonsei University at 1 site in South Korea.
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 3 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 13 May 2019. 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 South Korea. 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?
Uncorrected Distance Vision Acuity at each time point between the two groups. (time frame: preoperative). The study lists 4 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 13 May 2019.