MyopiaNCT05501795

The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200

An observational study of Myopia, run by Stephen Wexler at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit. 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® FS200 femtosecond laser
Type of treatment: Medical device
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 9 Aug 2022to 19 Jan 2023
Phase: Observational
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

Study population: Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Appropriate candidate for uncomplicated bilateral LASIK surgery
Gender: Males and Females.
Age: 18 or older.
Refractive error range - SE refractive errors up to 0 to -6D with maximum cylinder up to 3.00D
Stable refractive error <0.50D change in preceding year
Contact lens wear discontinued 3 days prior to pre-op exam and the procedure
Pachymetry above 490μm with residual greater than 270μm
Candidates who, as determined by the investigator, can safely undergo LASIK with a 120μm flap
Willing and able to provide written informed consent for participation in the study.
Willing and able to comply with scheduled visits and other study procedures.
Have good general and ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

Patients with usual relative and absolute contraindications for LASIK surgery (severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
Pachymetry below 490μm
Autoimmune or immunodeficiency diseases
Patients with signs of inability to understand consent for study and procedure planned
Patients with history of previous ocular surgery

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bismarck Lasik
Bismarck, North Dakota, 58501

Other trials in United States

About this study

The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.

Read the detailed description

This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.

Conditions: Myopia
Being tested: WaveLight® FS200 femtosecond laser
Keywords: FS200
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WaveLight® FS200 femtosecond laserDevice
Flap creation with the WaveLight® FS200 femtosecond laser

Study groups in NCT05501795
Study group	Role	What they receive
WaveLight® FS200 femtosecond laser		Flap creation with the WaveLight® FS200 femtosecond laser Receives: Device: WaveLight® FS200 femtosecond laser

What is being measured

The primary outcome is the main question the study is designed to answer.

The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
Measured: 1 day postoperative

Secondary outcomes (2)

The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan
Measured: 1 day postoperative
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam
Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam
Measured: Day 0 (surgical visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202219 Jan 2023

First posted15 Aug 2022
Study start9 Aug 2022
Primary completion19 Jan 2023
Study completion19 Jan 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 MyopiaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05501795
Sponsor's protocol ID: SW-22-001
Status last verified: Jun 2024
First submitted: 12 Aug 2022
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
ClinicalTrials.gov ID: NCT05501795
Acronym / sponsor ID: SW-22-001
Conditions: Myopia
Keywords: FS200
Study type: Observational
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Stephen WexlerUniversity, hospital or other
Collaborators: Sengi
Study start: 9 Aug 2022 (actual)
Primary completion: 19 Jan 2023 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 15 Aug 2022 (actual)
Results: Posted 12 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
WaveLight® FS200 femtosecond laser	–	Device: WaveLight® FS200 femtosecond laserFlap creation with the WaveLight® FS200 femtosecond laser

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

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® FS200 femtosecond laserFlap creation with the WaveLight® FS200 femtosecond laser	Device	WaveLight® FS200 femtosecond laser

Primary outcome

The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
Time frame: 1 day postoperative

2 secondary outcomes

The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan
Time frame: 1 day postoperative
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam
Time frame: Day 0 (surgical visit)

Results and safety

Results posted to the registry on 12 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WaveLight® FS200 Femtosecond Laser	58	58

Primary outcome: The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.

Time frame: 1 day postoperative. Mean (Standard Deviation). Unit: um

Measure	WaveLight® FS200 Femtosecond Laser n = 58
Value	0.64 (9)

Population analysed: 116 Eyes of 58 participants

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WaveLight® FS200 Femtosecond Laser	0 of 58 (0%)	0 of 58 (0%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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.

Stephen Wexler, MD principal investigator

Bismarck Lasik

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia, run by Stephen Wexler 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?

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 12 Jul 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 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?

The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit. (time frame: 1 day postoperative). 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 NCT05501795.

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 12 Jul 2024.