MyopiaNCT04219891
WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
A study testing WaveLight EX500 excimer laser system with InnovEyes sightmap, LASIK and InnovEyes sightmap in people with Myopia, run by Alcon Research at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- WaveLight EX500 excimer laser system with InnovEyes sightmap, LASIK and InnovEyes sightmap
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 Mar 2020to 9 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D, with MRSE no more than -12.00 D
- Best corrected photopic distance visual acuity of 20/20 or better
- Uncorrected photopic distance visual acuity of 20/40 or worse
- Stable refraction (within ± 0.50 D) as determined by MRSE for a minimum of 12 months prior to surgery
Who cannot join
- History or evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma (or suspect)
- Previous intraocular or corneal surgery
- Intent to have monovision treatment
- Other protocol-specified inclusion and exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Alcon Investigative Site
Chevy Chase, Maryland, 20815-7018
Alcon Investigative Site
Dallas, Texas, 75243
Price Vision Group
Indianapolis, Indiana, 46260
Alcon Investigative Site
Kansas City, Missouri, 64154
Alcon Investigative Site
Mt. Pleasant, South Carolina, 29464
Alcon Investigative Site
Omaha, Nebraska, 68135
Alcon Investigative Site
San Diego, California, 92122
Alcon Investigative Site
Sioux Falls, South Dakota, 57108
Alcon Investigative Site
St Louis, Missouri, 63017
About this study
Official title: Pivotal Trial of WaveLight® EX500 Excimer Laser System for the Correction of Myopia With and Without Astigmatism Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
The purpose of this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap.
Read the detailed description
Qualified subjects will receive treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Day 0 Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Year 1). The primary endpoints will be assessed at refractive stability, defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. Total expected duration of subject participation is approximately 1 year. This study will be conducted in the United States.
- Conditions
- Myopia
- Being tested
- WaveLight EX500 excimer laser system with InnovEyes sightmap, LASIK, InnovEyes sightmap
- Keywords
- LASIK, Ray Tracing, Myopia, Astigmatism
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveLight EX500 excimer laser system with InnovEyes sightmapDevice
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the WaveLight EX500 software will be upgraded to include the InnovEyes treatment.
LASIKProcedure or surgery
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system and data obtained from the InnovEyes sightmap.
InnovEyes sightmapDevice
Non-contact ophthalmic diagnostic device that captures images of the eye and collects ocular data preoperatively to generate a patient-specific ablation profile for refractive correction surgery
| Study group | Role | What they receive |
|---|---|---|
| WaveLight EX500 excimer laser system | Experimental | Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap Receives: Device: WaveLight EX500 excimer laser system with InnovEyes sightmap; Procedure: LASIK; Device: InnovEyes sightmap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability
Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive Stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Month 1, Month 3
Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Month 1, Month 3
Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place. BCDVA was measured in Snellen, where 20/20 indicates normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place and measured in logarithm Minimum Angle of Resolution, where each line on the letter chart represents 0.1 Snellen and 0.0 logMAR equates to 20/20 Snellen, or normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability
Manifest refractive astigmatism is the cylindrical portion of the subjective refraction. It is measured with ETDRS charts at a distance of 4 meters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start9 Mar 2020
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219891
- Sponsor's protocol ID
- RFP911-C001
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2020
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Trial of WaveLight® EX500 Excimer Laser System for the Correction of Myopia With and Without Astigmatism Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
- ClinicalTrials.gov ID
- NCT04219891
- Acronym / sponsor ID
- RFP911-C001
- Conditions
- Myopia
- Keywords
- LASIK, Ray Tracing, Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 6 Apr 2025
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 this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap.
Detailed description
Qualified subjects will receive treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Day 0 Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Year 1). The primary endpoints will be assessed at refractive stability, defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. Total expected duration of subject participation is approximately 1 year. This study will be conducted in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveLight EX500 excimer laser system | Experimental | Device: WaveLight EX500 excimer laser system with InnovEyes sightmap, Procedure: LASIK, Device: InnovEyes sightmapLaser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D, with MRSE no more than -12.00 D
- Best corrected photopic distance visual acuity of 20/20 or better
- Uncorrected photopic distance visual acuity of 20/40 or worse
- Stable refraction (within ± 0.50 D) as determined by MRSE for a minimum of 12 months prior to surgery
Key exclusion criteria (4 listed)
- History or evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma (or suspect)
- Previous intraocular or corneal surgery
- Intent to have monovision treatment
- Other protocol-specified inclusion and exclusion criteria may apply.
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 |
|---|---|---|
| WaveLight EX500 excimer laser system with InnovEyes sightmapFDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the WaveLight EX500 software will be upgraded to include the InnovEyes treatment. | Device | WaveLight EX500 excimer laser system |
| LASIKProcedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system and data obtained from the InnovEyes sightmap. | Procedure or surgery | WaveLight EX500 excimer laser system |
| InnovEyes sightmapNon-contact ophthalmic diagnostic device that captures images of the eye and collects ocular data preoperatively to generate a patient-specific ablation profile for refractive correction surgery | Device | WaveLight EX500 excimer laser system |
Primary outcome
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability
Time frame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability
Time frame: Month 1, Month 3
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive Stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability
Time frame: Month 1, Month 3
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D
Time frame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability
Time frame: Day -30 to -1 (preoperative), up to Month 3
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place. BCDVA was measured in Snellen, where 20/20 indicates normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability
Time frame: Day -30 to -1 (preoperative), up to Month 3
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place and measured in logarithm Minimum Angle of Resolution, where each line on the letter chart represents 0.1 Snellen and 0.0 logMAR equates to 20/20 Snellen, or normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability
Time frame: Day -30 to -1 (preoperative), up to Month 3
Manifest refractive astigmatism is the cylindrical portion of the subjective refraction. It is measured with ETDRS charts at a distance of 4 meters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability
Time frame: Up to Month 3
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sr. Clinical Trial Lead, Surgical study director
Alcon Research
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaveLight EX500 excimer laser system with InnovEyes sightmap, LASIK and InnovEyes sightmap in people with Myopia, run by Alcon Research at 9 sites 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 4 inclusion and 4 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability (time frame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.