Trial Outcomes & Findings for The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200 (NCT NCT05501795)

Results Overview

Recruitment status

COMPLETED

Target enrollment

58 participants

Primary outcome timeframe

1 day postoperative

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	WaveLight® FS200 Femtosecond Laser Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WaveLight® FS200 Femtosecond Laser n=58 Participants Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser
Age, Continuous	34.4 years STANDARD_DEVIATION 7.7 • n=58 Participants
Sex: Female, Male Female	26 Participants n=58 Participants
Sex: Female, Male Male	32 Participants n=58 Participants

PRIMARY outcome

Timeframe: 1 day postoperative

Population: 116 Eyes of 58 participants

Outcome measures

Outcome measures
Measure	WaveLight® FS200 Femtosecond Laser n=116 Eyes Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser	Pentacam Pachymetry as measured by the Oculus Pentacam
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.	0.64 um Standard Deviation 9	—

SECONDARY outcome

Timeframe: 1 day postoperative

Population: 116 Eyes of 58 participants

Outcome measures

Outcome measures
Measure	WaveLight® FS200 Femtosecond Laser n=116 Eyes Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser	Pentacam Pachymetry as measured by the Oculus Pentacam
The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan	0.02 mm Standard Deviation 0.05	—

SECONDARY outcome

Timeframe: Day 0 (surgical visit)

Population: 116 Eyes of 58 participants

Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam

Outcome measures

Outcome measures
Measure	WaveLight® FS200 Femtosecond Laser n=116 Eyes Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser	Pentacam n=116 Eyes Pachymetry as measured by the Oculus Pentacam
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam	555.2 um Standard Deviation 30.9	553.1 um Standard Deviation 29.4

Adverse Events

WaveLight® FS200 Femtosecond Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Stephen Wexler

Bismarck Lasik

Phone: 701-222-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place