A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intralase IFS	Intralase IFS150	Intralase IFS vs. Visumax
Visumax	Visumax	Visumax vs. Intralase iFS

Primary Outcome Measures

Name	Time	Method
ETDRS Uncorrected Visual Acuity	At post-operative month 12	Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes With LASIK	One month, three months, six months and twelve months	PROWL study questionnaire
Best Spectacle Corrected Visual Acuity	Postoperative month 12	Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation	At postoperative month twelve	Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Aberrometry	One three, six and twelve months	Aberrometry images will be obtained on the iDesign aberrometer
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness	At postoperative month one	Anterior segment ocular coherence tomography
Questionnaire Measuring Patient Preference for Laser Device	Intraoperative (Approximately 1 minute after completion of surgery)	Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.