An observational study in Myopia and Astigmatism, sponsored by Stanford University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Stanford University · Observational
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 61 is below the median of 150 across 173 observational studies indexed under Myopia.
Browse Myopia studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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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:
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.
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
Subjective Questionnaire
Time frame: 1 yr
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Stanford University