NCT03063164

A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Edward E. Manche · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Comparing LASIK outcomes using two femtosecond lasers

Detailed description

Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Intralase IFS150	Intralase flap creation
DEVICE	Visumax	Visumax flap creation

Timeline

• Start date: 2017-02-14
• Primary completion: 2018-11-13
• Completion: 2018-11-13
• First posted: 2017-02-24
• Last updated: 2021-12-14
• Results posted: 2021-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study