Comparison of Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Between Different Cap Thickness.

Myopia Clinical Trial

Official title:

Comparison of Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Between Different Cap Thickness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584555
• Other study ID #: 4-2017-0063
• Status: Completed
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: August 26, 2019

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Because corneal ectasia after refractive surgery is the one of most terrifying complication, corneal biomechanics has been drawn interests to many researchers and clinicians. Theoretically, SMILE may preserve corneal biomechanics better than LASIK, because the anterior stroma which is stiffer than the posterior stroma remains intact in SMILE. However, there are some controversies, because previous studies investigating corneal biomechanics have been reported inconsistent outcomes, although SMILE has been reported equal to or better than LASIK. Weakening of corneal biomechanics and iatrogenic corneal ectasia have also been reported after SMILE. In addition, because the tensile strength of cornea gradually decreases as it goes backwards, creating deeper refractive lenticule may result in stronger cornea by preserving more of anterior lamellae of the cornea. But on the contrary, leaving sufficient residual stromal bed has been known to be important in preventing iatrogenic corneal ectasia, hence creating thin cap may be effective and desirable. Although many researches have been investigated the difference in biomechanical response between SMILE and LASIK, there are few studies evaluating the dependence of cap thickness on postoperative biomechanical strength after SMILE. El-Massry et al. reported that the thicker cap thickness showed higher postoperative corneal hysteresis (CH) and corneal resistance factor (CRF) with Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Depew, NY) which may not be optimal for a clear description of the viscosity and elasticity of the cornea,3 ; however, other studies have been presented that there is no significant difference of corneal biomechanics with cap thickness. There is no comparative human study using Corvis ST (Oculus, Wetzlar, Germany) despite presence of the study using Corvis ST in rabbit eyes. Furthermore, no prospective study with large number of subjects has been performed to date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. age of 20 years or older.

2. Myopia

3. Who is willing to get SMILE surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Myopia
• Surgical Wound

Intervention

Procedure:
• SMILE using 120µm cap thickness
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 or 140 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 micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.
• SMILE using 140µm cap thickness
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 or 140 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 micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei Univeristy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Damgaard IB, Ivarsen A, Hjortdal J. Refractive Correction and Biomechanical Strength Following SMILE With a 110- or 160-µm Cap Thickness, Evaluated Ex Vivo by Inflation Test. Invest Ophthalmol Vis Sci. 2018 Apr 1;59(5):1836-1843. doi: 10.1167/iovs.17-23675. — View Citation

El-Massry AA, Goweida MB, Shama Ael-S, Elkhawaga MH, Abdalla MF. Contralateral Eye Comparison Between Femtosecond Small Incision Intrastromal Lenticule Extraction at Depths of 100 and 160 µm. Cornea. 2015 Oct;34(10):1272-5. doi: 10.1097/ICO.0000000000000571. — View Citation

Fernández J, Rodríguez-Vallejo M, Martínez J, Tauste A, Piñero DP. Corneal biomechanics after laser refractive surgery: Unmasking differences between techniques. J Cataract Refract Surg. 2018 Mar;44(3):390-398. doi: 10.1016/j.jcrs.2017.10.054. Epub 2018 Mar 31. Review. — View Citation

He M, Wang W, Ding H, Zhong X. Comparison of Two Cap Thickness in Small Incision Lenticule Extraction: 100µm versus 160µm. PLoS One. 2016 Sep 21;11(9):e0163259. doi: 10.1371/journal.pone.0163259. eCollection 2016. — View Citation

Liu M, Zhou Y, Wu X, Ye T, Liu Q. Comparison of 120- and 140-µm SMILE Cap Thickness Results in Eyes With Thick Corneas. Cornea. 2016 Oct;35(10):1308-14. doi: 10.1097/ICO.0000000000000924. — View Citation

Weng S, Liu M, Yang X, Liu F, Zhou Y, Lin H, Liu Q. Evaluation of Human Corneal Lenticule Quality After SMILE With Different Cap Thicknesses Using Scanning Electron Microscopy. Cornea. 2018 Jan;37(1):59-65. doi: 10.1097/ICO.0000000000001404. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Distance Vision Acuity	Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.	from preoperative to postoperative 6 months
Primary	Corrected Distance vision Acuity	Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.	from preoperative to postoperative 6 months
Secondary	1.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".; 1,2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	2.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".; 1,2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	3.Spherical aberration at each time point between the two groups.	3,4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	4.Spherical aberration changes from baseline at each postoperative time point between the two groups.	3,4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	5.Coma aberration at each time point between the two groups.	5,6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.; Corneal biomechanics including deformation amplitude ratio (DA ratio), and stiffness parameter at first applanation (SP-A1) is examined using Corvis ST (Oculus, Wetzlar, Germany). The unit of SP-A1 is "mm Hg/mm", and DA ratio is unitless.	from preoperative to postoperative 6 months
Secondary	6.Coma aberration changes from baseline at each postoperative time point between the two groups.	5,6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.; Corneal biomechanics including deformation amplitude ratio (DA ratio), and stiffness parameter at first applanation (SP-A1) is examined using Corvis ST (Oculus, Wetzlar, Germany). The unit of SP-A1 is "mm Hg/mm", and DA ratio is unitless.	from preoperative to postoperative 6 months
Secondary	7.Deformation amplitude ratio (DA ratio) at each time point between the two groups.	7,8 DA ratio at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	8.DA ratio changes from baseline at each postoperative time point between the two groups.	7,8 DA ratio at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	9.Stiffness parameter at first applanation (SP-A1) at each time point between the two groups.	9,10 SP-A1 at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months
Secondary	10.SP-A1 changes from baseline at each postoperative time point between the two groups.	9,10 SP-A1 at each time point and change from baseline at each time point will be compared between the two groups.	from preoperative to postoperative 6 months