Clinical trial NCT04919291: Direct Comparison of TG and WFO LASIK
Official title: Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratomileusis, Laser In Situ
Contrast Sensitivity
Lead sponsor: Taipei Nobel Eye Clinic
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual acuity
timeFrame: 3 months after surgery
measure: Corneal wavefront analysis
timeFrame: 3-months postoperative visit
measure: Contrast sensitivity
timeFrame: 3-months postoperative visit
measure: Quality of vision questionnaire
timeFrame: 3-months postoperative visit
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Nobel Eye Clinic
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.