Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03947944
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2019-05-09
Brief Title:
Clinical Outcomes of Small-incision Lenticule Extraction SMILE Using Vector Planning Method
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Clinical Outcomes of Small-incision Lenticule Extraction SMILE Using Vector Planning Method
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 073 to 081 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
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 073 to 081 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None