HyperopiaNCT04805593
Clinical Investigation of the WaveLight® EX500 Excimer Laser
A study testing WaveLight EX500 excimer laser system and LASIK in people with Hyperopia and Hyperopic Astigmatism, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperopia, Hyperopic Astigmatism
- What is being tested?
- WaveLight EX500 excimer laser system and LASIK
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Apr 2021to 2 May 2023
- 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
- Intended to treat bilaterally;
- Hyperopia with or without astigmatism as specified in the protocol;
- Stable vision as specified in the protocol;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Glaucoma;
- Cataracts;
- Previous eye surgery;
- Intent to have monovision treatment;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Physicians Protocol
Greensboro, North Carolina, 27401
Mann Eye Institute
Houston, Texas, 77004
Moyes Eye Center
Kansas City, Missouri, 64154
Durrie Vision
Overland Park, Kansas, 66210
Vance Thompson Vision ND
West Fargo, North Dakota, 58078
About this study
Official title: Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.
Read the detailed description
Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.
- Conditions
- Hyperopia, Hyperopic Astigmatism
- Being tested
- WaveLight EX500 excimer laser system, LASIK
- Keywords
- LASIK, Refractive errors
- Medical subject headings
- Hyperopia, Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveLight EX500 excimer laser systemDevice
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 Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
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.
| 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 system Receives: Device: WaveLight EX500 excimer laser system; Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Manifest Refraction 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. Refractive stability was 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. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
Measured: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
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. Refractive stability was 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. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.
Measured: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
An AE 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). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.
Measured: Up to Month 12 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start28 Apr 2021
- Primary completion2 May 2023
- Study completion2 May 2023
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 HyperopiaStudies 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
- 44 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, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805593
- Sponsor's protocol ID
- RFD530-P001
- Status last verified
- Aug 2024
- First submitted
- 16 Mar 2021
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
- ClinicalTrials.gov ID
- NCT04805593
- Acronym / sponsor ID
- RFD530-P001
- Conditions
- Hyperopia, Hyperopic Astigmatism
- Keywords
- LASIK, Refractive errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Posted 23 May 2024
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 collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.
Detailed description
Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.
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, Procedure: LASIKLaser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intended to treat bilaterally;
- Hyperopia with or without astigmatism as specified in the protocol;
- Stable vision as specified in the protocol;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Glaucoma;
- Cataracts;
- Previous eye surgery;
- Intent to have monovision treatment;
- Other protocol-defined 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 systemFDA 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 Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism. | 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. | Procedure or surgery | WaveLight EX500 excimer laser system |
Primary outcome
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
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. Refractive stability was 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. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
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. Refractive stability was 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. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
Time frame: Up to Month 12 postoperative
An AE 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). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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, LLC
5 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 and LASIK in people with Hyperopia and Hyperopic Astigmatism, run by Alcon Research at 5 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 5 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 23 May 2024). 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 Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability (time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)). The study lists 3 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 21 Aug 2024.