Association Between ORA and Residual Refractive Astigmatism After SMILE

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.

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Key information

Conditions

Refractive Errors Astigmatism Eye Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Nobel Eye Clinic

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Corrected distance visual acuity

Time frame: 3 months after surgery

in LogMAR unit
Manifest refraction

Time frame: 3 months after surgery

in Diopter

Sponsors and collaborators

Lead sponsor

Taipei Nobel Eye Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Nov 3, 2022
Registry last updated: Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed