An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:3/9/2019
Start Date:April 2011
End Date:December 2018

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A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS

The purpose of the study is to compare the results of LASIK surgery when using two versions
of a femtosecond laser in patients with nearsightedness with and without astigmatism.

The 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 we will inform the patient and make an appropriate
referral. if the patient is deemed appropriate for the study after a comprehensive
examination included computerized videokeratography, then they can be enrolled. The patient
will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase FS
60 and which eye is treated with Intralase IFS will be randomized so there is a 50% chance
for either eye to receive one treatment. The patients will be seen on the day of surgery,
post op day one, one month, three months, six months and one year. The patient will receive
topical antibiotics in each eye for one week following the procedure. The patient will
receive pred forte 1% ophthalmic drops for one week after treatment. The patient 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.

Inclusion Criteria:

- Subjects age 21 and older with healthy eyes.

- Nearsightedness between -0.25 diopters and -7.00 diopters with or without astigmatism
of up to 3.00 diopters.

Exclusion Criteria:

- Subjects under the age of 21.

- Patients with excessively thin corneas.

- Patients with topographic evidence of keratoconus.

- Patients with ectactic eye disorders.

- Patients with autoimmune diseases.
We found this trial at
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
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Stanford, CA
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