Refractive ErrorsNCT05604872
Association Between ORA and Residual Refractive Astigmatism After SMILE
An observational study of Refractive Errors and Astigmatism, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Refractive Errors, Astigmatism
- What is being tested?
- Small Incision Lenticule Extraction
- Type of treatment
- Surgery or procedure
- How many people
- 530 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study was conducted by retrospective chart review in Taipei Nobel Eye Clinic from 2020 to 2022.
Who may be able to join
- 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
Who cannot join
- Cataract
- Corneal opacities or irregularities
- Dry eye (Schirmer's test I ≤ 5mm)
- Amblyopia
- Coexisting ocular pathologies
- Glaucoma
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery
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
- Being tested
- Small Incision Lenticule Extraction
- Medical subject headings
- Refractive Errors, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Incision Lenticule ExtractionProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity
in LogMAR unit
Measured: 3 months after surgery
Manifest refraction
in Diopter
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Nobel Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Kai Chang, Taipei Nobel Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604872
- Sponsor's protocol ID
- 003
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32271519Jun 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.
PubMed 32347695Chao 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.
PubMed 37470969
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery
- ClinicalTrials.gov ID
- NCT05604872
- Acronym / sponsor ID
- 003
- Conditions
- Refractive Errors, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Taipei Nobel Eye ClinicUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study was conducted by retrospective chart review in Taipei Nobel Eye Clinic from 2020 to 2022.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- Cataract
- Corneal opacities or irregularities
- Dry eye (Schirmer's test I ≤ 5mm)
- Amblyopia
- Coexisting ocular pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Incision Lenticule ExtractionA 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 | Procedure or surgery | – |
Primary outcome
Corrected distance visual acuity
Time frame: 3 months after surgery
in LogMAR unit
Manifest refraction
Time frame: 3 months after surgery
in Diopter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Results publication: PubMed 32271519Gyldenkerne 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.
- Results publication: PubMed 32347695Jun 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.
- Derived from this study: PubMed 37470969Chao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Astigmatism, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected distance visual acuity (time frame: 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604872, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.