Direct Comparison of TG and WFO LASIK

NCT04919291 | Completed

• 1 other identifier: 002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratomileusis, Laser In Situ; Contrast Sensitivity

Outcome Measures

Primary Outcomes (4)

• Visual acuity

  uncorrected visual acuity and corrected distance visual acuity

  3 months after surgery

• Corneal wavefront analysis

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

  3-months postoperative visit

• Contrast sensitivity

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

  3-months postoperative visit

• Quality of vision questionnaire

  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

  3-months postoperative visit

Study Arms (2)

Topoguided LASIK

ACTIVE COMPARATOR

Topoguided ablation profile on dominant eye

Device: Topoguided LASIK

Wavefront optimized LASIK

ACTIVE COMPARATOR

Wavefront optimized ablation profile on non-dominant eye

Device: Wavefront optimized LASIK

Interventions

Topoguided LASIK DEVICE

Topoguided ablation profile on dominant eye

Topoguided LASIK

Wavefront optimized LASIK DEVICE

Wavefront optimized ablation profile on non-dominant eye

Wavefront optimized LASIK

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Nobel Eye Clinic: lead

Study Sites (1)

Taipei Nobel Eye Clinic

Taipei, Taiwan

Location

Related Publications (7)

• Sutton G, Lawless M, Hodge C. Laser in situ keratomileusis in 2012: a review. Clin Exp Optom. 2014 Jan;97(1):18-29. doi: 10.1111/cxo.12075. Epub 2013 Jun 21.

  PMID: 23786377 BACKGROUND

• Moreno-Barriuso E, Lloves JM, Marcos S, Navarro R, Llorente L, Barbero S. Ocular aberrations before and after myopic corneal refractive surgery: LASIK-induced changes measured with laser ray tracing. Invest Ophthalmol Vis Sci. 2001 May;42(6):1396-403.

  PMID: 11328757 BACKGROUND

• Schallhorn SC, Farjo AA, Huang D, Boxer Wachler BS, Trattler WB, Tanzer DJ, Majmudar PA, Sugar A; American Academy of Ophthalmology. Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Jul;115(7):1249-61. doi: 10.1016/j.ophtha.2008.04.010.

  PMID: 18598819 BACKGROUND

• Stonecipher K, Parrish J, Stonecipher M. Comparing wavefront-optimized, wavefront-guided and topography-guided laser vision correction: clinical outcomes using an objective decision tree. Curr Opin Ophthalmol. 2018 Jul;29(4):277-285. doi: 10.1097/ICU.0000000000000495.

  PMID: 29787391 BACKGROUND

• Kim J, Choi SH, Lim DH, Yang CM, Yoon GJ, Chung TY. Topography-guided versus wavefront-optimized laser in situ keratomileusis for myopia: Surgical outcomes. J Cataract Refract Surg. 2019 Jul;45(7):959-965. doi: 10.1016/j.jcrs.2019.01.031. Epub 2019 Jun 10.

  PMID: 31196580 BACKGROUND

• Kim J, Choi SH, Lim DH, Yoon GJ, Chung TY. Comparison of outcomes after topography-modified refraction versus wavefront-optimized versus manifest topography-guided LASIK. BMC Ophthalmol. 2020 May 14;20(1):192. doi: 10.1186/s12886-020-01459-0.

  PMID: 32410588 BACKGROUND

• Ozulken K, Yuksel E, Tekin K, Kiziltoprak H, Aydogan S. Comparison of Wavefront-Optimized Ablation and Topography-Guided Contoura Ablation With LYRA Protocol in LASIK. J Refract Surg. 2019 Apr 1;35(4):222-229. doi: 10.3928/1081597X-20190304-02.

  PMID: 30984979 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Nobel Eye Institute

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: June 9, 2021
• Study Start: September 26, 2019
• Primary Completion: March 14, 2020
• Study Completion: June 30, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)