Association Between ORA and Residual Refractive Astigmatism After SMILE

Astigmatism Clinical Trial

Official title:

Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604872
• Other study ID #: 003
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Taipei Nobel Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of our study is to analysis and compare the relationship between ORA and postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D) astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Corrected distance visual acuity of both eyes reaches 0.1 logarithm of the minimum angle of resolution (logMAR)

• Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes

Exclusion Criteria:

• Cataract

• Corneal opacities or irregularities

• Dry eye (Schirmer's test I = 5mm)

• Amblyopia

• Coexisting ocular pathologies

• Glaucoma

• Non-dilating pupil

• History of intraocular surgery, laser therapy, or retinopathy

• Optic nerve or macular diseases

• Estimated postoperative cornea residual stromal thickness less than 250 µm

• Pregnancy or under lactation

• Uncontrolled diabetic mellitus or systemic immune disease _Refusal or unable to maintain follow-up

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Procedure:
• Small Incision Lenticule Extraction
A 500 kHzVisumax (Carl Zeiss Meditec AG) femtosecond laser was used with cap thickness ranging from 100 to 130µm, cap diameter from 7.3 to 7.9 mm. The lenticule was dissected with a blunt spatula through a 30 to 60-degree incision at the 10 o'clock position and removed using forceps afterward. Treatment targets of both eyes were set to emmetropia, the refraction corrections were based on manifest refractions

Locations

Country	Name	City	State
Taiwan	Taipei Nobel Eye Clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Nobel Eye Clinic

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Gyldenkerne A, Hjortdal J, Ivarsen A. Astigmatism prediction in small-incision lenticule extraction. J Cataract Refract Surg. 2020 Apr;46(4):524-533. doi: 10.1097/j.jcrs.0000000000000083. — View Citation

Jun I, Kang DSY, Arba-Mosquera S, Reinstein DZ, Archer TJ, Jean SK, Kim EK, Seo KY, Lee HK, Kim TI. Comparison of clinical outcomes between vector planning and manifest refraction planning in SMILE for myopic astigmatism. J Cataract Refract Surg. 2020 Aug — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected distance visual acuity	in LogMAR unit	3 months after surgery
Primary	Manifest refraction	in Diopter	3 months after surgery