MyopiaPhase 4LASIKNCT01454843
LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser
A Phase 4 study testing Wavefront-guided LASIK - Allegretto and Wavefront-guided LASIK - AMO in people with Myopia and Astigmatism, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Wavefront-guided LASIK - Allegretto and Wavefront-guided LASIK - AMO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 23 Jun 2012
- Phase
- Phase 4
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Who cannot join
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
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- Patients must have similar levels of nearsightedness with or without astigmatism in each eye.
- They can not be more than 1.5 diopters of difference between eyes.
- Patients must have similar levels of astigmatism in each eye.
- They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Official title: A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser
The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.
Read the detailed description
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound research design.
- Conditions
- Myopia, Astigmatism
- Being tested
- Wavefront-guided LASIK - Allegretto, Wavefront-guided LASIK - AMO
- Keywords
- Myopia, Astigmatism, Aberrations, Wavefront, LASIK, Wavefront LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavefront-guided LASIK - AllegrettoProcedure or surgery
Also called Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser
Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
Wavefront-guided LASIK - AMOProcedure or surgery
Also called AMO Visx CustomVue S4 IR excimer laser
Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
| Study group | Role | What they receive |
|---|---|---|
| Wavefront-guided LASIK - Allegretto | Active comparator | Wavefront-guided LASIK using the Allegretto excimer laser. Receives: Procedure: Wavefront-guided LASIK - Allegretto |
| Wavefront-guided LASIK - AMO | Active comparator | Wavefront-guided LASIK using AMO CustomVue excimer laser. Receives: Procedure: Wavefront-guided LASIK - AMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.
Measured: 1 year
Secondary outcomes (4)
Low contrast visual acuity
Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).
Measured: 1 year
Higher order aberrations
Measure changes in higher order aberrations.
Measured: 1 year
Safety
Will will assess safety by measuring change in best spectacle corrected visual acuity. We will record the number of eyes that gain, lose or have no change in the best spectacle corrected visual acuity after the surgery. This is measured using snellen visual acuity charts. The ideal outcome would be that there were no loss of any lines of best spectacle corrected visual acuity and a high percentage of gains of lines of best spectacle corrected visual acuity.
Measured: One year
Predictability
Percentage of eyes within +/- 0.5 diopters of the intended correction
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study start1 Apr 2009
- Primary completion31 Mar 2011
- Study completion23 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454843
- Sponsor's protocol ID
- 21220
- Acronym
- LASIK
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2011
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.
PubMed 25321951He L, Manche EE. Prospective randomized contralateral eye evaluation of subjective quality of vision after wavefront-guided or wavefront- optimized photorefractive keratectomy. J Refract Surg. 2014 Jan;30(1):6-12. doi: 10.3928/1081597X-20131217-01.
PubMed 24868564Lee WS, Manche EE. Comparison of simulated keratometric changes following wavefront-guided and wavefront-optimized myopic laser-assisted in situ keratomileusis. Clin Ophthalmol. 2018 Mar 29;12:613-619. doi: 10.2147/OPTH.S161387. eCollection 2018.
PubMed 29636597He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.
PubMed 24560995Sales CS, Manche EE. One-year outcomes from a prospective, randomized, eye-to-eye comparison of wavefront-guided and wavefront-optimized LASIK in myopes. Ophthalmology. 2013 Dec;120(12):2396-2402. doi: 10.1016/j.ophtha.2013.05.010. Epub 2013 Jun 15.
PubMed 23778091Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014.
PubMed 25419115
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser
- ClinicalTrials.gov ID
- NCT01454843
- Acronym / sponsor ID
- LASIK / 21220
- Conditions
- Myopia, Astigmatism
- Keywords
- Myopia, Astigmatism, Aberrations, Wavefront, LASIK, Wavefront LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 31 Mar 2011 (actual)
- Study completion
- 23 Jun 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- 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.
The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.
Detailed description
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound research design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wavefront-guided LASIK - Allegretto | Active comparator | Procedure: Wavefront-guided LASIK - AllegrettoWavefront-guided LASIK using the Allegretto excimer laser. |
| Wavefront-guided LASIK - AMO | Active comparator | Procedure: Wavefront-guided LASIK - AMOWavefront-guided LASIK using AMO CustomVue excimer laser. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Key exclusion criteria (10 listed)
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients with autoimmune diseases.
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 |
|---|---|---|
| Wavefront-guided LASIK - AllegrettoAlso: Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laserWavefront-guided LASIK using the Allegretto excimer laser for myopia. | Procedure or surgery | Wavefront-guided LASIK - Allegretto |
| Wavefront-guided LASIK - AMOAlso: AMO Visx CustomVue S4 IR excimer laserWavefront-guided LASIK using the AMO CustomVue excimer laser for myopia. | Procedure or surgery | Wavefront-guided LASIK - AMO |
Primary outcome
Efficacy
Time frame: 1 year
Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.
4 secondary outcomes
Low contrast visual acuity
Time frame: 1 year
Higher order aberrations
Time frame: 1 year
Safety
Time frame: One year
Predictability
Time frame: One year
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 11 Apr 2022.
- Background: PubMed 25321951He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.
- Background: PubMed 24868564He L, Manche EE. Prospective randomized contralateral eye evaluation of subjective quality of vision after wavefront-guided or wavefront- optimized photorefractive keratectomy. J Refract Surg. 2014 Jan;30(1):6-12. doi: 10.3928/1081597X-20131217-01.
- Background: PubMed 29636597Lee WS, Manche EE. Comparison of simulated keratometric changes following wavefront-guided and wavefront-optimized myopic laser-assisted in situ keratomileusis. Clin Ophthalmol. 2018 Mar 29;12:613-619. doi: 10.2147/OPTH.S161387. eCollection 2018.
- Background: PubMed 24560995He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.
- Background: PubMed 23778091Sales CS, Manche EE. One-year outcomes from a prospective, randomized, eye-to-eye comparison of wavefront-guided and wavefront-optimized LASIK in myopes. Ophthalmology. 2013 Dec;120(12):2396-2402. doi: 10.1016/j.ophtha.2013.05.010. Epub 2013 Jun 15.
- Background: PubMed 25419115Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014.
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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.
Edward E Manche, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wavefront-guided LASIK - Allegretto and Wavefront-guided LASIK - AMO in people with Myopia and Astigmatism, run by Stanford University at 1 site in United States.
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 2 inclusion and 10 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 11 Apr 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy (time frame: 1 year). 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 NCT01454843, which also lists 6 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 11 Apr 2022.