Association Between ORA and Residual Refractive Astigmatism After SMILE

Completed

• Conditions: Refractive Errors; Astigmatism

• Registration Number: NCT05604872
• Lead Sponsor: Taipei Nobel Eye Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity	3 months after surgery	in LogMAR unit
Manifest refraction	3 months after surgery	in Diopter

Trial Locations

Locations (1)

Taipei Nobel Eye Clinic; 🇨🇳 Taipei, Taiwan