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

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT01365728

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Astigmatism	Procedure: LASIK with the iFS femtosecond laser

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.

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

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

Actual Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Outcome Measures

Primary Outcome Measures

Changes in Best Spectacle Corrected Visual Acuity [One year]
Changes in 5% low contrast best corrected visual acuity [One year]
Changes in corneal sensation [One year]
Uncorrected Visual Acuity [One year]
Stability of refractive outcome [One year]
Changes in 25% low contrast best corrected visual acuity [One year]

Secondary Outcome Measures

Subjective Questionnaire [1 yr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.