Association Between ORA and Residual Refractive Astigmatism After SMILE
NCT ID: NCT05604872
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
530 participants
OBSERVATIONAL
2020-06-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes
Exclusion Criteria
* 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
20 Years
50 Years
ALL
No
Sponsors
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Taipei Nobel Eye Clinic
OTHER
Responsible Party
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Chao-Kai Chang
Dean
Locations
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Taipei Nobel Eye Clinic
Taipei, , Taiwan
Countries
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References
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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.
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.
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.
Other Identifiers
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003
Identifier Type: -
Identifier Source: org_study_id
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