Direct Comparison of TG and WFO LASIK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2020-06-30

Brief Summary

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To compare the efficacy to different profiles, direct head-to-head studies had been conducted. In one previous review study revealed that TG LASIK provided patient with better uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous contralateral eye studies also showed that TG LASIK induced less postoperative higher-order aberration than WFO LASIK. However, these studies included only low-to-moderate myopia patients, for patients with high myopia (spherical equivalent \> 6D), the effect of TG LASIK comparing with WFO LASIK had not been reported before.

The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.

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Detailed Description

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Conditions

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Keratomileusis, Laser In Situ Contrast Sensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topoguided LASIK

Topoguided ablation profile on dominant eye

Group Type ACTIVE_COMPARATOR

Topoguided LASIK

Intervention Type DEVICE

Topoguided ablation profile on dominant eye

Wavefront optimized LASIK

Wavefront optimized ablation profile on non-dominant eye

Group Type ACTIVE_COMPARATOR

Wavefront optimized LASIK

Intervention Type DEVICE

Wavefront optimized ablation profile on non-dominant eye

Interventions

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Topoguided LASIK

Topoguided ablation profile on dominant eye

Intervention Type DEVICE

Wavefront optimized LASIK

Wavefront optimized ablation profile on non-dominant eye

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age between 20 and 50 years old
* CDVA of both eyes could reach 0.1 logarithm of the minimum angle of resolution (logMAR)
* stable refractive errors of myopia and astigmatism

Exclusion Criteria

* cataract
* corneal opacities or irregularities
* dry eye (Schirmer's test I ≤ 5mm)
* amblyopia
* coexisting ocular pathologies
* glaucoma
* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No