The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
1 other identifier
observational
58
1 country
1
Brief Summary
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2022
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2023
CompletedResults Posted
Study results publicly available
July 12, 2024
CompletedJuly 12, 2024
June 1, 2024
5 months
August 12, 2022
December 7, 2023
June 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
1 day postoperative
Secondary Outcomes (2)
The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan
1 day postoperative
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam
Day 0 (surgical visit)
Study Arms (1)
WaveLight® FS200 femtosecond laser
Flap creation with the WaveLight® FS200 femtosecond laser
Interventions
Flap creation with the WaveLight® FS200 femtosecond laser
Eligibility Criteria
Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stephen Wexlerlead
- Sengicollaborator
Study Sites (1)
Bismarck Lasik
Bismarck, North Dakota, 58501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Stephen Wexler
- Organization
- Bismarck Lasik
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Wexler, MD
Bismarck Lasik
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director and Surgeon
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 15, 2022
Study Start
August 9, 2022
Primary Completion
January 19, 2023
Study Completion
January 19, 2023
Last Updated
July 12, 2024
Results First Posted
July 12, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share