Direct Comparison of TG and WFO LASIK

Taipei Nobel Eye Clinic (Other)
Overall Status
Completed ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Topoguided LASIK
  • Device: Wavefront optimized LASIK

Study Design

Study Type:
Actual Enrollment :
21 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
Actual Study Start Date :
Sep 26, 2019
Actual Primary Completion Date :
Mar 14, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Topoguided LASIK

Topoguided ablation profile on dominant eye

Device: Topoguided LASIK
Topoguided ablation profile on dominant eye

Active Comparator: Wavefront optimized LASIK

Wavefront optimized ablation profile on non-dominant eye

Device: Wavefront optimized LASIK
Wavefront optimized ablation profile on non-dominant eye

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [3 months after surgery]

    uncorrected visual acuity and corrected distance visual acuity

  2. Corneal wavefront analysis [3-months postoperative visit]

    horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration

  3. Contrast sensitivity [3-months postoperative visit]

    4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).

  4. 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

Eligibility Criteria


Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 Taipei Nobel Eye Clinic Taipei Taiwan

Sponsors and Collaborators

  • Taipei Nobel Eye Clinic


None specified.

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Chao-Kai Chang, Dean, Nobel Eye Institute, Taipei Nobel Eye Clinic Identifier:
Other Study ID Numbers:
  • 002
First Posted:
Jun 9, 2021
Last Update Posted:
Jun 9, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2021