Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Using Vector Planning Method.

• ClinicalTrials.gov Identifier: NCT03947944
• Recruitment Status: Completed
• First Posted: May 13, 2019
• Last Update Posted: May 13, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Myopic Astigmatism	Procedure: SMILE using manifest refraction planning; Procedure: SMILE using vector planning	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Using Vector Planning Method.
• Actual Study Start Date: August 16, 2018
• Actual Primary Completion Date: May 7, 2019
• Actual Study Completion Date: May 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: manifest refraction planning group; The subjects underwent SMILE using manifest refraction planning.	Procedure: SMILE using manifest refraction planning; 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.
Active Comparator: vector planning group; The subjects underwent SMILE using vector planning.	Procedure: SMILE using vector planning; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. Total higher order aberration at each time point between the two groups. [ Time Frame: preoperative ]

   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. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

2. Total higher order aberration at each time point between the two groups. [ Time Frame: postoperative 1 month ]

   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. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

3. Total higher order aberration at each time point between the two groups. [ Time Frame: 3 months ]

   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. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

4. Total higher order aberration at each time point between the two groups. [ Time Frame: 6 months ]

   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. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

5. Total higher order aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: preoperative ]

   Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".

   2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

6. Total higher order aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: postoperative 1 month ]

   Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".

   2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

7. Total higher order aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 3 months ]

   Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".

   2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

8. Total higher order aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 6 months ]

   Total higher order aberrations, spherical aberrations, and coma aberrations are examined using Keratron Scout (Optikon 2000, Rome, Italy). The unit of those is "μm".

   2. Total higher order aberrations at each time point and change from baseline at each time point will be compared between the two groups.

9. Spherical aberration at each time point between the two groups. [ Time Frame: preoperative ]
   3. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
10. Spherical aberration at each time point between the two groups. [ Time Frame: postoperative 1 month ]
    3. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
11. Spherical aberration at each time point between the two groups. [ Time Frame: 3 months ]
    3. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
12. Spherical aberration at each time point between the two groups. [ Time Frame: 6 months ]
    3. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
13. Spherical aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: preoperative ]
    4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
14. Spherical aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: postoperative 1 month ]
    4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
15. Spherical aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 3 months ]
    4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
16. Spherical aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 6 months ]
    4. Spherical aberrations at each time point and change from baseline at each time point will be compared between the two groups.
17. Coma aberration at each time point between the two groups. [ Time Frame: preoperative ]
    5. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
18. Coma aberration at each time point between the two groups. [ Time Frame: postoperative 1 month ]
    5. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
19. Coma aberration at each time point between the two groups. [ Time Frame: 3 months ]
    5. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
20. Coma aberration at each time point between the two groups. [ Time Frame: 6 months ]
    5. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
21. Coma aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: preoperative ]
    6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
22. Coma aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: postoperative 1 month ]
    6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
23. Coma aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 3 months ]
    6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.
24. Coma aberration changes from baseline at each postoperative time point between the two groups. [ Time Frame: 6 months ]
    6. Coma aberrations at each time point and change from baseline at each time point will be compared between the two groups.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, Korea, Republic of, 03722

Sponsors and Collaborators

Yonsei University

More Information

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03947944
• Other Study ID Numbers: 1-2018-0038
• First Posted: May 13, 2019
• Last Update Posted: May 13, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:

Small incision lenticule extraction; astigmatism; vector planning

Additional relevant MeSH terms:

Astigmatism; Surgical Wound; Wounds and Injuries; Refractive Errors; Eye Diseases