Trial Outcomes & Findings for LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser (NCT NCT02060461)

NCT ID: NCT02060461

Last Updated: 2018-03-23

Results Overview

Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-03-23

Participant Flow

Participant milestones

Measure	Comparison of Femtosecond Lasers in LASIK Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 femtosecond laser in one eye and the IntraLase in the other.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser

Baseline characteristics by cohort

Measure	Comparison of Femtosecond Lasers in LASIK n=33 Participants Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 laser in one eye and the IntraLase in the other.
Age, Continuous	30.5 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Contralateral eyes

Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.

Outcome measures

Measure	FS200 Femtosecond Laser LASIK n=33 eyes FS200 laser used to create LASIK flap	IntraLase Femtosecond Laser LASIK n=33 eyes IntraLase femtosecond laser used to create LASIK flap
Evaluation of LASIK Flap Thickness	105.8 micrometers Standard Deviation 10.3	112.9 micrometers Standard Deviation 8.2

Adverse Events

FS200 Femtosecond Laser LASIK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IntraLase Femotsecond Laser LASIK

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

William J Dupps, Jr, MD, PhD

Cleveland Clinic

Phone: 216-444-8396

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place