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

T

Tianjin Eye Hospital

Status

Completed

Conditions

Myopia

Treatments

Procedure: small incision lenticular extraction

Study type

Observational

Funder types

Other

Identifiers

NCT05017376
TJYYLL-202034

Details and patient eligibility

About

Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

group A
Description:
small optical zone
Treatment:
Procedure: small incision lenticular extraction
group B
Description:
large optical zone
Treatment:
Procedure: small incision lenticular extraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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