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

Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05017376
Enrollment
140
Registered
2021-08-23
Start date
2020-08-01
Completion date
2021-08-01
Last updated
2021-08-23

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

Conditions

Myopia

Keywords

small incision lenticule extraction, vector analysis

Brief summary

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.

Interventions

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

Sponsors

Tianjin Eye Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
astigmatic changes2021.03Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)
error value2021.04Target refraction (TR) and surgically induced refraction (SIR) under different optical zones

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026