Direct Comparison of TG and WFO LASIK

Contrast Sensitivity Clinical Trial

Official title:

Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919291
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2021
• Source: Taipei Nobel Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contrast Sensitivity
• Hypersensitivity
• Keratomileusis, Laser In Situ

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Nobel Eye Clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Nobel Eye Clinic

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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. — View 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. Erratum in: BMC Ophthalmol. 2020 Dec 29;20(1):492. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	uncorrected visual acuity and corrected distance visual acuity	3 months after surgery
Primary	Corneal wavefront analysis	horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration	3-months postoperative visit
Primary	Contrast sensitivity	4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).	3-months postoperative visit
Primary	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