Direct Comparison of TG and WFO LASIK

Taipei Nobel Eye Clinic

Status: Completed

Conditions: Keratomileusis, Laser In Situ; Contrast Sensitivity

Treatments: Device: Wavefront optimized LASIK; Device: Topoguided LASIK

Study type: Interventional

Funder types: Other

Identifiers

NCT04919291

002

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Topoguided LASIK

Active Comparator group

Description:

Topoguided ablation profile on dominant eye

Treatment:

Device: Topoguided LASIK

Wavefront optimized LASIK

Active Comparator group

Description:

Wavefront optimized ablation profile on non-dominant eye

Treatment:

Device: Wavefront optimized LASIK