Trials / Completed
CompletedNCT05501795
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 58 (actual)
- Sponsor
- Stephen Wexler · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WaveLight® FS200 femtosecond laser | Flap creation with the WaveLight® FS200 femtosecond laser |
Timeline
- Start date
- 2022-08-09
- Primary completion
- 2023-01-19
- Completion
- 2023-01-19
- First posted
- 2022-08-15
- Last updated
- 2024-07-12
- Results posted
- 2024-07-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05501795. Inclusion in this directory is not an endorsement.