Keratomileusis, Laser In SituNCT04919291
Direct Comparison of TG and WFO LASIK
A study testing Topoguided LASIK and Wavefront optimized LASIK in people with Keratomileusis, Laser In Situ and Contrast Sensitivity, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Keratomileusis, Laser In Situ, Contrast Sensitivity
- What is being tested?
- Topoguided LASIK and Wavefront optimized LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- cataract
- corneal opacities or irregularities
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
- coexisting ocular pathologies
- glaucoma
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contralateral Comparison of Togoguided LASIK and Wavefront-optimized 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.
- Being tested
- Topoguided LASIK, Wavefront optimized LASIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topoguided LASIKDevice
Topoguided ablation profile on dominant eye
Wavefront optimized LASIKDevice
Wavefront optimized ablation profile on non-dominant eye
| Study group | Role | What they receive |
|---|---|---|
| Topoguided LASIK | Active comparator | Topoguided ablation profile on dominant eye Receives: Device: Topoguided LASIK |
| Wavefront optimized LASIK | Active comparator | Wavefront optimized ablation profile on non-dominant eye Receives: Device: Wavefront optimized LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
uncorrected visual acuity and corrected distance visual acuity
Measured: 3 months after surgery
Corneal wavefront analysis
horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Measured: 3-months postoperative visit
Contrast sensitivity
4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
Measured: 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
Measured: 3-months postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start26 Sep 2019
- Primary completion14 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Keratomileusis, Laser In SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Nobel Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Kai Chang, Taipei Nobel Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919291
- Sponsor's protocol ID
- 002
- Status last verified
- Jun 2021
- First submitted
- 23 Mar 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23786377Moreno-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.
PubMed 11328757Schallhorn 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.
PubMed 18598819Stonecipher 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.
PubMed 29787391Kim 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.
PubMed 31196580Kim 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.
PubMed 32410588Ozulken 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.
PubMed 30984979
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
- ClinicalTrials.gov ID
- NCT04919291
- Acronym / sponsor ID
- 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Taipei Nobel Eye ClinicUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topoguided LASIK | Active comparator | Device: Topoguided LASIKTopoguided ablation profile on dominant eye |
| Wavefront optimized LASIK | Active comparator | Device: Wavefront optimized LASIKWavefront optimized ablation profile on non-dominant eye |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- cataract
- corneal opacities or irregularities
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
- coexisting ocular pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topoguided LASIKTopoguided ablation profile on dominant eye | Device | Topoguided LASIK |
| Wavefront optimized LASIKWavefront optimized ablation profile on non-dominant eye | Device | Wavefront optimized LASIK |
Primary outcome
Visual acuity
Time frame: 3 months after surgery
uncorrected visual acuity and corrected distance visual acuity
Corneal wavefront analysis
Time frame: 3-months postoperative visit
horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Contrast sensitivity
Time frame: 3-months postoperative visit
4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Background: PubMed 23786377Sutton 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.
- Background: PubMed 11328757Moreno-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.
- Background: PubMed 18598819Schallhorn 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.
- Background: PubMed 29787391Stonecipher 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.
- Background: PubMed 31196580Kim 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.
- Background: PubMed 32410588Kim 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.
- Background: PubMed 30984979Ozulken 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topoguided LASIK and Wavefront optimized LASIK in people with Keratomileusis, Laser In Situ and Contrast Sensitivity, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919291, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.