Byers Eye Institute at Stanford
Palo Alto, California, 94303, United States
NCT Number: NCT03063164
Comparing LASIK outcomes using two femtosecond lasers
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Notify Me21 year–60 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94303, United States
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 the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intralase flap creation
Visumax flap creation
Time frame: At post-operative month 12
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time frame: At postoperative month one
Anterior segment ocular coherence tomography
Time frame: At postoperative month twelve
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Time frame: Postoperative month 12
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time frame: One three, six and twelve months
Aberrometry images will be obtained on the iDesign aberrometer
Time frame: Intraoperative (Approximately 1 minute after completion of surgery)
Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
Time frame: One month, three months, six months and twelve months
PROWL study questionnaire
Edward E. Manche
Other
A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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