Clinical trial NCT01365728: An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness
Official title: A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Astigmatism
Keywords: Femtosecond Laser
FS60
iFS
Intralase
Wavefront-guided LASIK
IntraLASIK
LASIK
Myopia
Nearsightedness
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectactic eye disorders.
* Patients with autoimmune diseases.

Primary outcomes:
measure: Changes in Best Spectacle Corrected Visual Acuity
timeFrame: One year
measure: Changes in 5% low contrast best corrected visual acuity
timeFrame: One year
measure: Changes in corneal sensation
timeFrame: One year
measure: Uncorrected Visual Acuity
timeFrame: One year
measure: Stability of refractive outcome
timeFrame: One year
measure: Changes in 25% low contrast best corrected visual acuity
timeFrame: One year
Secondary outcomes:
measure: Subjective Questionnaire
timeFrame: 1 yr
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Edward E. Manche
role: PRINCIPAL_INVESTIGATOR
References: