Clinical trial NCT03063164: A Comparison of LASIK Outcomes Using Two Femtosecond Lasers
Official title: A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: Femtosecond laser
Visumax
Intralase IFS150
LASIK
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eye to eye comparison
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria:

* Subjects under the age of 21
* Subjects over the age of 60
* Subjects with corneal ectatic disorders

Primary outcomes:
measure: ETDRS Uncorrected Visual Acuity
timeFrame: At post-operative month 12
Secondary outcomes:
measure: Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
timeFrame: At postoperative month one
measure: Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
timeFrame: At postoperative month twelve
measure: Best Spectacle Corrected Visual Acuity
timeFrame: Postoperative month 12
measure: Aberrometry
timeFrame: One three, six and twelve months
measure: Questionnaire Measuring Patient Preference for Laser Device
timeFrame: Intraoperative (Approximately 1 minute after completion of surgery)
measure: Patient Reported Outcomes With LASIK
timeFrame: One month, three months, six months and twelve months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Edward Manche, MD
role: PRINCIPAL_INVESTIGATOR
References: