Direct Comparison of TG and WFO LASIK
Primary Purpose
Keratomileusis, Laser In Situ, Contrast Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Topoguided LASIK
Wavefront optimized LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Keratomileusis, Laser In Situ
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
Sites / Locations
- Taipei Nobel Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Topoguided LASIK
Wavefront optimized LASIK
Arm Description
Topoguided ablation profile on dominant eye
Wavefront optimized ablation profile on non-dominant eye
Outcomes
Primary Outcome Measures
Visual acuity
uncorrected visual acuity and corrected distance visual acuity
Corneal wavefront analysis
horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Contrast sensitivity
4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04919291
Brief Title
Direct Comparison of TG and WFO LASIK
Official Title
Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Nobel Eye Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratomileusis, Laser In Situ, Contrast Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topoguided LASIK
Arm Type
Active Comparator
Arm Description
Topoguided ablation profile on dominant eye
Arm Title
Wavefront optimized LASIK
Arm Type
Active Comparator
Arm Description
Wavefront optimized ablation profile on non-dominant eye
Intervention Type
Device
Intervention Name(s)
Topoguided LASIK
Intervention Description
Topoguided ablation profile on dominant eye
Intervention Type
Device
Intervention Name(s)
Wavefront optimized LASIK
Intervention Description
Wavefront optimized ablation profile on non-dominant eye
Primary Outcome Measure Information:
Title
Visual acuity
Description
uncorrected visual acuity and corrected distance visual acuity
Time Frame
3 months after surgery
Title
Corneal wavefront analysis
Description
horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Time Frame
3-months postoperative visit
Title
Contrast sensitivity
Description
4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
Time Frame
3-months postoperative visit
Title
Quality of vision questionnaire
Description
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
Time Frame
3-months postoperative visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Taipei Nobel Eye Clinic
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23786377
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.
Results Reference
background
PubMed Identifier
11328757
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.
Results Reference
background
PubMed Identifier
18598819
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.
Results Reference
background
PubMed Identifier
29787391
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.
Results Reference
background
PubMed Identifier
31196580
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.
Results Reference
background
PubMed Identifier
32410588
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.
Results Reference
background
PubMed Identifier
30984979
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.
Results Reference
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Direct Comparison of TG and WFO LASIK
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