Overview

This trial is active, not recruiting.

Conditions myopia, astigmatism
Treatment lasik with the ifs femtosecond laser
Sponsor Stanford University
Start date April 2011
End date December 2017
Trial size 60 participants
Trial identifier NCT01365728, SU-05212011-7804, Stanford IRB Protocol # 21250

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Changes in Best Spectacle 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
Uncorrected Visual Acuity
time frame: One year
Stability of refractive outcome
time frame: One year
Changes in 25% low contrast best corrected visual acuity
time frame: One year

Secondary Outcomes

Measure
Subjective Questionnaire
time frame: 1 yr

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS
Principal investigator Edward E. Manche
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Stanford University.