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CompletedNCT05017376Updated Aug 23, 2021

Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis

An observational study in Myopia, sponsored by Tianjin Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-23.

Sponsored by Tianjin Eye Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140
Ages
18 Years to 45 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Myopia

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Keywords

  • small incision lenticule extraction
  • vector analysis
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In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 140 is close to the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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);

Exclusion criteria

Exclusion Criteria:

  • history of intraocular surgery
  • pupil diameter, >4.9 mm or \<2.78mm
  • keratoconus or corneal ectasia
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • group A

    small optical zone

    Procedure: small incision lenticular extraction

  • group B

    large optical zone

    Procedure: small incision lenticular extraction

Interventions

  • Proceduresmall incision lenticular extraction

    In patients with the same degree of myopia, different optical zones were designed for operation

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What researchers measure

Primary outcomes

  1. astigmatic changes

    Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)

    Time frame: 2021.03

  2. error value

    Target refraction (TR) and surgically induced refraction (SIR) under different optical zones

    Time frame: 2021.04

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Study locations

1 site
  • Tianjin Eye Hospital
    Tianjin, China
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References and documents

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 33154614 ↗
  • Dishler 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05017376
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Aug 23, 2021
Start date
Aug 1, 2020
Primary completion
Dec 31, 2020
Completion
Aug 1, 2021
Last update
Aug 23, 2021

Study contacts

Yan Wang
study chair · Tianjin Eye Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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