MyopiaNCT05017376
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
An observational study of Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Myopia
- What is being tested?
- small incision lenticular extraction
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2021
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: age of patients between 18-45 years; spherical refraction of -3.00 to -6.00 diopters (D) with or without astigmatism (<-3.00 D); spherical equivalent, -3.00 to -6.00 D; corrected distant visual acuity (CDVA), >20/25
Who may be able to join
- no ocular conditions
- normal topography
- central corneal thickness, >500µm
- residual stromal thickness, >280 µm
- pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);
Who cannot join
- history of intraocular surgery
- pupil diameter, >4.9 mm or <2.78mm
- keratoconus or corneal ectasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.
Read the detailed description
To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.
- Conditions
- Myopia
- Being tested
- small incision lenticular extraction
- Keywords
- small incision lenticule extraction, vector analysis
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small incision lenticular extractionProcedure or surgery
In patients with the same degree of myopia, different optical zones were designed for operation
| Study group | Role | What they receive |
|---|---|---|
| group A | small optical zone Receives: Procedure: small incision lenticular extraction | |
| group B | large optical zone Receives: Procedure: small incision lenticular extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
astigmatic changes
Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)
Measured: 2021.03
error value
Target refraction (TR) and surgically induced refraction (SIR) under different optical zones
Measured: 2021.04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017376
- Sponsor's protocol ID
- TJYYLL-202034
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moshirfar M, Thomson AC, West WB Jr, Hall MN, McCabe SE, Thomson RJ, Ronquillo YC, Hoopes PC. Initial Single-Site Experience Using SMILE for the Treatment of Astigmatism in Myopic Eyes and Comparison of Astigmatic Outcomes with Existing Literature. Clin Ophthalmol. 2020 Oct 29;14:3551-3562. doi: 10.2147/OPTH.S276899. eCollection 2020.
PubMed 33154614Dishler JG, Slade S, Seifert S, Schallhorn SC. Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial. Ophthalmology. 2020 Aug;127(8):1020-1034. doi: 10.1016/j.ophtha.2020.01.010. Epub 2020 Jan 15.
PubMed 32173114
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis
- ClinicalTrials.gov ID
- NCT05017376
- Acronym / sponsor ID
- TJYYLL-202034
- Conditions
- Myopia
- Keywords
- small incision lenticule extraction, vector analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 23 Aug 2021 (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.
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.
Detailed description
To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: small incision lenticular extractionsmall optical zone |
| group B | – | Procedure: small incision lenticular extractionlarge optical zone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- age of patients between 18-45 years; spherical refraction of -3.00 to -6.00 diopters (D) with or without astigmatism (<-3.00 D); spherical equivalent, -3.00 to -6.00 D; corrected distant visual acuity (CDVA), >20/25
Key inclusion criteria (5 listed)
- no ocular conditions
- normal topography
- central corneal thickness, >500µm
- residual stromal thickness, >280 µm
- pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);
Key exclusion criteria (3 listed)
- history of intraocular surgery
- pupil diameter, >4.9 mm or <2.78mm
- keratoconus or corneal ectasia
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 lenticular extractionIn patients with the same degree of myopia, different optical zones were designed for operation | Procedure or surgery | group A, group B |
Primary outcome
astigmatic changes
Time frame: 2021.03
Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)
error value
Time frame: 2021.04
Target refraction (TR) and surgically induced refraction (SIR) under different optical zones
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 23 Aug 2021.
- Results publication: PubMed 33154614Moshirfar M, Thomson AC, West WB Jr, Hall MN, McCabe SE, Thomson RJ, Ronquillo YC, Hoopes PC. Initial Single-Site Experience Using SMILE for the Treatment of Astigmatism in Myopic Eyes and Comparison of Astigmatic Outcomes with Existing Literature. Clin Ophthalmol. 2020 Oct 29;14:3551-3562. doi: 10.2147/OPTH.S276899. eCollection 2020.
- Results publication: PubMed 32173114Dishler JG, Slade S, Seifert S, Schallhorn SC. Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial. Ophthalmology. 2020 Aug;127(8):1020-1034. doi: 10.1016/j.ophtha.2020.01.010. Epub 2020 Jan 15.
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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.
Yan Wang study chair
Tianjin Eye Hospital
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 Myopia, run by Tianjin Eye Hospital at 1 site in China.
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 5 inclusion and 3 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 23 Aug 2021. 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 China. 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?
astigmatic changes (time frame: 2021.03). 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 NCT05017376, which also lists 2 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 23 Aug 2021.