A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Stanford University
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Uncorrected Visual Acuity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Edward E. Manche
Professor of Ophthalmology
Stanford University
Eligibility Criteria
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
- •Patients with excessively thin corneas.
- •Patients with topographic evidence of keratoconus.
- •Patients with ectactic eye disorders.
- •Patients with autoimmune diseases.
Outcomes
Primary Outcomes
Uncorrected Visual Acuity
Time Frame: One year
Stability of refractive outcome
Time Frame: One year
Changes in Best Spectacle Corrected Visual Acuity
Time Frame: One year
Changes in 25% low contrast best corrected visual acuity
Time Frame: One year
Changes in 5% low contrast best corrected visual acuity
Time Frame: One year
Changes in corneal sensation
Time Frame: One year
Secondary Outcomes
- Subjective Questionnaire(1 yr)