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Association Between ORA and Residual Refractive Astigmatism After SMILE

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604872
Enrollment
530
Registered
2022-11-03
Start date
2020-06-01
Completion date
2022-06-30
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors, Astigmatism

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.

Interventions

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

Sponsors

Taipei Nobel Eye Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corrected distance visual acuity3 months after surgeryin LogMAR unit
Manifest refraction3 months after surgeryin Diopter

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026