A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Study Overview
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Brief Summary
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Comparing LASIK outcomes using two femtosecond lasers

Detailed Description
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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.

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

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: Intralase IFS150
* Device: Visumax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eye to eye comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralase IFS<br>Intralase IFS vs. Visumax | Device: Intralase IFS150<br>* Intralase flap creation<br>|
| Active Comparator: Visumax<br>Visumax vs. Intralase iFS | Device: Visumax<br>* Visumax flap creation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | At post-operative month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness | Anterior segment ocular coherence tomography | At postoperative month one | 
| Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal. | At postoperative month twelve | 
| Best Spectacle Corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts | Postoperative month 12 | 
| Aberrometry | Aberrometry images will be obtained on the iDesign aberrometer | One three, six and twelve months | 
| Questionnaire Measuring Patient Preference for Laser Device | 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. | Intraoperative (Approximately 1 minute after completion of surgery) | 
| Patient Reported Outcomes With LASIK | PROWL study questionnaire | One month, three months, six months and twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK, Femtosecond laser, Visumax, Intralase IFS150