NCT03947944

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

Completed NA Last updated 13 May 2019

What this trial tests

NA trial testing SMILE using manifest refraction planning in Myopic Astigmatism in 114 participants. Completed in 7 May 2019.

Timeline

16 August 2018

Primary endpoint
7 May 2019

7 May 2019

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	16 August 2018
Primary completion	7 May 2019
Estimated completion	7 May 2019
Sites	1 location across South Korea

Drugs / interventions tested

• SMILE using manifest refraction planning
• SMILE using vector planning

Conditions studied

• Myopic Astigmatism — all drugs for Myopic Astigmatism →

Sponsor

Yonsei University

Who can join

Adults 20 to 45, any sex, with Myopic Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.