Refractive ErrorNCT02844556
International Multicenter Study on SMILE Surgery
A study testing SMILE surgery and FS-LASIK surgery in people with Refractive Error, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to carry out an international multicenter trial to get more convincing and valuable results of the SMILE surgery and compare the outcomes between the SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis) surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Refractive Error
- What is being tested?
- SMILE surgery and FS-LASIK surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- at baseline, be within the age range of 18 to 45 years old inclusive
- normal corneal morphology with no corneal nebula or corneal macula, the range of preoperative K2 (the steep curvature of the 3mm area at the center of cornea) from 38.0 to 47.0 diopter
- manifest spherical equivalent of -1.0 to -10.0 diopters (D)
- cylindrical diopter no more than -5.0D
- refractive diopter maintained stable for more than2 years
Show all 11Show fewer
- preoperative BCVA≥0.8, and the scotopic pupil diameter≥5.0mm when measured by WASCA analyzer (Carl Zeiss Meditec AG)
- picked off soft contact lens for more than 2 weeks
- picked off RGP for more than 1 month
- preoperative corneal central thickness measured by Pentacam >500μm, non-contact IOP<21mmHg
- be willing to comply with the clinical trial visit schedule as directed by the investigator.
Who cannot join
- any corneal diseases, corneal operations, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
- corneal macula and obvious pannus; current enrolment in another clinical trial/research project.
Trial locations and contacts
1 site in 1 country.
Yan Wang, director contact
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin
Yan Wang, director, +86-02227305083, wangyan7143@vip.sina.com
About this study
Official title: International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
The purpose of this study is to carry out an international multicenter trial to get more convincing and valuable results of the SMILE surgery and compare the outcomes between the SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis) surgery.
The investigators hope to investigate the differences between the SMILE and the FS-LASIK surgery comprehensively, including the comparison of visual acuity, refraction, the correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the corneal ectasia, the characteristics of the changes of central corneal thickness and the complications. To meet the demands of a multi center trial, all the examination equipments should be same in each center, and this will limit the variations within a study
Read the detailed description
Hypothesis: To compare the novel refractive surgery (SMILE, the intervention group) with traditional refractive surgery (FS-LASIK, the control group) in terms of visual acuity, the higher order aberrations, corneal biomechanical parameters and the complications. SMILE surgery might offer some advantages in some aspects compared with FS-LASIK surgery.
Study program
The procedures of the study are listed as follows:
All the participants accept the refractive surgery which were selected at first, and patients' routine postoperative examinations included UCVA, BCVA, slit lamp microscopy, non-contact IOP, corneal topography with the Scheimpflug tomography system, ocular higher order aberrations using the WASCA analyzer (Carl Zeiss Meditec AG), corneal biomechanical properties acquired by the Ocular Response Analyzer and/or the Corvis ST (Corvis ST, OCULUS, Wetzlar, Germany) at 1 week, 1 month, 3 months and 6 months follow-up periods after surgery.
Statistics:
Patients who have decided to choose the SMILE surgery or the FS-LASIK will be selected as participants. The propensity matching method will be used to choose proper cases for the two groups. The propensity matching method can be calculated by SPSS software. The independent variables include: the central corneal thickness (CCT), the Km (mean Pentacam keratometry), the spherical diopter (from manifest refraction), and the cylindrical diopter (from manifest refraction), the UCVA, the BCVA, the corneal resistance factor (CRF) and the corneal hysteresis (CH) (if the investigator have the Ocular Response Analyzer) of the cornea at preoperative. The closest score of eyes in the two groups will be matched.
The data will be preserved by each site, and will be systematically collected and analyzed by TianjinEH center. The statistical expert Dr Hayes from American Pacific University will be the statistical consultant, and will also in charge of the sample size calculation, the instructor of statistical analysis, and the quality control.
- Conditions
- Refractive Error
- Being tested
- SMILE surgery, FS-LASIK surgery
- Keywords
- SMILE surgery, FS-LASIK surgery, multicenter
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILE surgeryProcedure or surgery
SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
FS-LASIK surgeryOther
SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
| Study group | Role | What they receive |
|---|---|---|
| SMILE surgery | Other | Small incision lenticule extraction (SMILE) has become a novel and effective method for the correction of myopia and myopic astigmatism. It is a micro-invasive and flapless refractive procedure that has been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. Receives: Procedure: SMILE surgery |
| FS-LASIK surgery | Other | FS-LASIK surgery is femtosecond laser assisted- conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. Receives: Other: FS-LASIK surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected visual acuity
Measured: change from baseline with EDTRS chart at 6 months
Secondary outcomes (11)
uncorrected visual acuity
Measured: change from baseline with EDTRS chart at 6 months
spherical diopter
Measured: change from baseline with manifest refraction at 6 months
cylindrical dioptor
Measured: change from baseline with manifest refraction at 6 months
central corneal thickness
Measured: change from baseline with the Pentacam system at 6 months
corneal curvature assessed by the Pentacam system
Measured: change from baseline with mean Pentacam keratometry at 6 months
corneal resistance factor assessed by the Ocular Response Analyzer
Measured: change from baseline at 6 months
corneal hysteresis assessed by the Ocular Response Analyzer
Measured: change from baseline at 6 months
deformation amplitude assessed by the Corvis ST system
Measured: change from baseline at 6 months
spherical aberration
Measured: change from baseline with the WASCA system at 6 months
coma aberration
Measured: change from baseline with the WASCA system at 6 months
complication
Measured: intraoperative and postoperative at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nethradhama Superspeciality Eye Hospital, Alexandria University, Belgian Ocular Laser Centre, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jinan Mingshui Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study director, Tianjin Eye HospitalSri Ganesh, professor, Principal investigator, Nethradhama Superspeciality Eye HospitalBernard Heintz, professor, Principal investigator, Belgian Ocular Laser CentreOsama Ibrahim, professor, Principal investigator, Cornea Center, Alexandria UniversityKeming Yu, professor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityYulin Lei, professor, Principal investigator, Jinan Mingshui Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844556
- Sponsor's protocol ID
- Tianjin EH-SMILE
- Status last verified
- May 2018
- First submitted
- 12 Jul 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wei S, Wang Y. Comparison of corneal sensitivity between FS-LASIK and femtosecond lenticule extraction (ReLEx flex) or small-incision lenticule extraction (ReLEx smile) for myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1645-54. doi: 10.1007/s00417-013-2272-0. Epub 2013 Feb 7.
PubMed 23389552Wang Y, Bao XL, Tang X, Zuo T, Geng WL, Jin Y. [Clinical study of femtosecond laser corneal small incision lenticule extraction for correction of myopia and myopic astigmatism]. Zhonghua Yan Ke Za Zhi. 2013 Apr;49(4):292-8. Chinese.
PubMed 23900086Wu D, Wang Y, Zhang L, Wei S, Tang X. Corneal biomechanical effects: small-incision lenticule extraction versus femtosecond laser-assisted laser in situ keratomileusis. J Cataract Refract Surg. 2014 Jun;40(6):954-62. doi: 10.1016/j.jcrs.2013.07.056. Epub 2014 Apr 18.
PubMed 24751146Li X, Wang Y, Dou R. Aberration compensation between anterior and posterior corneal surfaces after Small incision lenticule extraction and Femtosecond laser-assisted laser in-situ keratomileusis. Ophthalmic Physiol Opt. 2015 Sep;35(5):540-51. doi: 10.1111/opo.12226. Epub 2015 Jun 18.
PubMed 26087672Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.
PubMed 25618419
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Study on Small Incision Lenticule Extraction(SMILE) Surgery
- ClinicalTrials.gov ID
- NCT02844556
- Acronym / sponsor ID
- Tianjin EH-SMILE
- Conditions
- Refractive Error
- Keywords
- SMILE surgery, FS-LASIK surgery, multicenter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Collaborators
- Nethradhama Superspeciality Eye Hospital, Alexandria University, Belgian Ocular Laser Centre, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jinan Mingshui Eye Hospital
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Jul 2016 (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.
The purpose of this study is to carry out an international multicenter trial to get more convincing and valuable results of the SMILE surgery and compare the outcomes between the SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis) surgery.
The investigators hope to investigate the differences between the SMILE and the FS-LASIK surgery comprehensively, including the comparison of visual acuity, refraction, the correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the corneal ectasia, the characteristics of the changes of central corneal thickness and the complications. To meet the demands of a multi center trial, all the examination equipments should be same in each center, and this will limit the variations within a study
Detailed description
Hypothesis: To compare the novel refractive surgery (SMILE, the intervention group) with traditional refractive surgery (FS-LASIK, the control group) in terms of visual acuity, the higher order aberrations, corneal biomechanical parameters and the complications. SMILE surgery might offer some advantages in some aspects compared with FS-LASIK surgery.
Study program
The procedures of the study are listed as follows:
All the participants accept the refractive surgery which were selected at first, and patients' routine postoperative examinations included UCVA, BCVA, slit lamp microscopy, non-contact IOP, corneal topography with the Scheimpflug tomography system, ocular higher order aberrations using the WASCA analyzer (Carl Zeiss Meditec AG), corneal biomechanical properties acquired by the Ocular Response Analyzer and/or the Corvis ST (Corvis ST, OCULUS, Wetzlar, Germany) at 1 week, 1 month, 3 months and 6 months follow-up periods after surgery.
Statistics:
Patients who have decided to choose the SMILE surgery or the FS-LASIK will be selected as participants. The propensity matching method will be used to choose proper cases for the two groups. The propensity matching method can be calculated by SPSS software. The independent variables include: the central corneal thickness (CCT), the Km (mean Pentacam keratometry), the spherical diopter (from manifest refraction), and the cylindrical diopter (from manifest refraction), the UCVA, the BCVA, the corneal resistance factor (CRF) and the corneal hysteresis (CH) (if the investigator have the Ocular Response Analyzer) of the cornea at preoperative. The closest score of eyes in the two groups will be matched.
The data will be preserved by each site, and will be systematically collected and analyzed by TianjinEH center. The statistical expert Dr Hayes from American Pacific University will be the statistical consultant, and will also in charge of the sample size calculation, the instructor of statistical analysis, and the quality control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMILE surgery | Other | Procedure: SMILE surgerySmall incision lenticule extraction (SMILE) has become a novel and effective method for the correction of myopia and myopic astigmatism. It is a micro-invasive and flapless refractive procedure that has been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. |
| FS-LASIK surgery | Other | Other: FS-LASIK surgeryFS-LASIK surgery is femtosecond laser assisted- conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- at baseline, be within the age range of 18 to 45 years old inclusive
- normal corneal morphology with no corneal nebula or corneal macula, the range of preoperative K2 (the steep curvature of the 3mm area at the center of cornea) from 38.0 to 47.0 diopter
- manifest spherical equivalent of -1.0 to -10.0 diopters (D)
- cylindrical diopter no more than -5.0D
Key exclusion criteria (2 listed)
- any corneal diseases, corneal operations, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
- corneal macula and obvious pannus; current enrolment in another clinical trial/research project.
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 surgerySMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. | Procedure or surgery | SMILE surgery |
| FS-LASIK surgerySMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries. | Other | FS-LASIK surgery |
Primary outcome
corrected visual acuity
Time frame: change from baseline with EDTRS chart at 6 months
11 secondary outcomes
uncorrected visual acuity
Time frame: change from baseline with EDTRS chart at 6 months
spherical diopter
Time frame: change from baseline with manifest refraction at 6 months
cylindrical dioptor
Time frame: change from baseline with manifest refraction at 6 months
central corneal thickness
Time frame: change from baseline with the Pentacam system at 6 months
corneal curvature assessed by the Pentacam system
Time frame: change from baseline with mean Pentacam keratometry at 6 months
corneal resistance factor assessed by the Ocular Response Analyzer
Time frame: change from baseline at 6 months
corneal hysteresis assessed by the Ocular Response Analyzer
Time frame: change from baseline at 6 months
deformation amplitude assessed by the Corvis ST system
Time frame: change from baseline at 6 months
spherical aberration
Time frame: change from baseline with the WASCA system at 6 months
coma aberration
Time frame: change from baseline with the WASCA system at 6 months
complication
Time frame: intraoperative and postoperative at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 23389552Wei S, Wang Y. Comparison of corneal sensitivity between FS-LASIK and femtosecond lenticule extraction (ReLEx flex) or small-incision lenticule extraction (ReLEx smile) for myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1645-54. doi: 10.1007/s00417-013-2272-0. Epub 2013 Feb 7.
- Background: PubMed 23900086Wang Y, Bao XL, Tang X, Zuo T, Geng WL, Jin Y. [Clinical study of femtosecond laser corneal small incision lenticule extraction for correction of myopia and myopic astigmatism]. Zhonghua Yan Ke Za Zhi. 2013 Apr;49(4):292-8. Chinese.
- Background: PubMed 24751146Wu D, Wang Y, Zhang L, Wei S, Tang X. Corneal biomechanical effects: small-incision lenticule extraction versus femtosecond laser-assisted laser in situ keratomileusis. J Cataract Refract Surg. 2014 Jun;40(6):954-62. doi: 10.1016/j.jcrs.2013.07.056. Epub 2014 Apr 18.
- Background: PubMed 26087672Li X, Wang Y, Dou R. Aberration compensation between anterior and posterior corneal surfaces after Small incision lenticule extraction and Femtosecond laser-assisted laser in-situ keratomileusis. Ophthalmic Physiol Opt. 2015 Sep;35(5):540-51. doi: 10.1111/opo.12226. Epub 2015 Jun 18.
- Background: PubMed 25618419Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.
- 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.
Yan Wang, director contact
Yan Wang, director study director
Tianjin Eye Hospital
Sri Ganesh, professor principal investigator
Nethradhama Superspeciality Eye Hospital
Bernard Heintz, professor principal investigator
Belgian Ocular Laser Centre
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 surgery and FS-LASIK surgery in people with Refractive Error, run by Tianjin Eye 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 11 inclusion and 2 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 4 May 2018. 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 Yan Wang, director (wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corrected visual acuity (time frame: change from baseline with EDTRS chart at 6 months). 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 NCT02844556, which also lists 5 linked publications.
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 4 May 2018.