Direct Comparison of TG and WFO LASIK

Not Applicable

Completed

• Conditions: Contrast Sensitivity; Keratomileusis, Laser In Situ
• Interventions: Device: Topoguided LASIK; Device: Wavefront optimized LASIK

• Registration Number: NCT04919291
• Lead Sponsor: Taipei Nobel Eye Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Primary Completion: 2020-03-14
• Study Completion: 2020-06-30
• Study First Submitted: 2021-03-23
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topoguided LASIK	Topoguided LASIK	Topoguided ablation profile on dominant eye
Wavefront optimized LASIK	Wavefront optimized LASIK	Wavefront optimized ablation profile on non-dominant eye

Primary Outcome Measures

Name	Time	Method
Corneal wavefront analysis	3-months postoperative visit	horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Contrast sensitivity	3-months postoperative visit	4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
Quality of vision questionnaire	3-months postoperative visit	A 11-item questionnaire, item scores range from 0 to 10 and higher item scores in questionnaire indicated more difficulty in achieving specific visual tasks
Visual acuity	3 months after surgery	uncorrected visual acuity and corrected distance visual acuity

Trial Locations

Locations (1)

Taipei Nobel Eye Clinic; 🇨🇳 Taipei, Taiwan