Association Between ORA and Residual Refractive Astigmatism After SMILE

NCT05604872 | Completed

• 1 other identifier: 003
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractive Errors; Astigmatism

Outcome Measures

Primary Outcomes (2)

• Corrected distance visual acuity

  in LogMAR unit

  3 months after surgery

• Manifest refraction

  in Diopter

  3 months after surgery

Interventions

Small Incision Lenticule Extraction PROCEDURE

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study was conducted by retrospective chart review in Taipei Nobel Eye Clinic from 2020 to 2022.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Nobel Eye Clinic: lead

Study Sites (1)

Taipei Nobel Eye Clinic

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 32271519 RESULT

• 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;46(8):1149-1158. doi: 10.1097/j.jcrs.0000000000000100.

  PMID: 32347695 RESULT

• Chao CC, Lin MY, Chang CK. The Association Between Ocular Residual Astigmatism and the Efficacy of Astigmatism Correction Via Small Incision Lenticule Extraction (SMILE). Ophthalmol Ther. 2023 Oct;12(5):2631-2640. doi: 10.1007/s40123-023-00766-1. Epub 2023 Jul 20.

  PMID: 37470969 DERIVED

MeSH Terms

Conditions

Refractive Errors; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 3, 2022
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)