An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS|
- Changes in Best Spectacle Corrected Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Changes in 5% low contrast best corrected visual acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
- Changes in corneal sensation [ Time Frame: One year ] [ Designated as safety issue: No ]
- Uncorrected Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
- Stability of refractive outcome [ Time Frame: One year ] [ Designated as safety issue: No ]
- Changes in 25% low contrast best corrected visual acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
- Subjective Questionnaire [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Myopic eyes undergoing LASIK with 2 femtosescond lasers||
Procedure: LASIK with the iFS femtosecond laser
Patients will undergo bilateral simultaneous LASIK surgery for myopia. One eye will have a LASIK flap created with the Intralase FS60 and the fellow eye will have a LASIK flap created with the Intralase iFS. Both eyes will undergo wavefront-guided LASIK surgery with the Visx CustomVue excimer laser.
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.
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Edward E. Manche||Stanford University|