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Completed

NCT Number: NCT04919291

Direct Comparison of TG and WFO LASIK

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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Key information

Conditions

Keratomileusis, Laser In Situ Contrast Sensitivity

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Nobel Eye Clinic

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topoguided LASIK

Device

Topoguided ablation profile on dominant eye

WaveFront Optimized LASIK

Device

Wavefront optimized ablation profile on non-dominant eye

Primary outcomes

  1. Visual acuity

    Time frame: 3 months after surgery

    uncorrected visual acuity and corrected distance visual acuity

  2. Corneal wavefront analysis

    Time frame: 3-months postoperative visit

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

  3. Contrast sensitivity

    Time frame: 3-months postoperative visit

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

  4. Quality of vision questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taipei Nobel Eye Clinic

Other

Registry information

Official study title

Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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