A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 22 - 59 |
| Updated: | 9/9/2018 |
| Start Date: | March 12, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Edward E Manche, MD |
| Email: | edward.manche@stanford.edu |
| Phone: | 650 725-5765 |
A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to
correct myopia.
correct myopia.
Subjects 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 subject from the study, then we will inform the patient and make an appropriate
referral. if the subject is deemed appropriate for the study after a comprehensive
examination included computerized videokeratography, then they can be enrolled. Subjects will
undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which
eye is treated with SMILE will be randomized so there is a 50% chance for either eye to
receive one treatment. Subjects will be seen on the day of surgery, post op day one, one
week, one month, three months, six months and one year. Subjects will receive topical
antibiotics in each eye for one week following the procedure. Subjects will receive topical
steroid ophthalmic drops for one week after treatment. Subjects will also receive topical
antibiotic ophthalmic drops for four days after treatment. All of this is within the usual
and customary standard of care for the treatment of subjects undergoing LASIK and SMILE
surgery.
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 subject from the study, then we will inform the patient and make an appropriate
referral. if the subject is deemed appropriate for the study after a comprehensive
examination included computerized videokeratography, then they can be enrolled. Subjects will
undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which
eye is treated with SMILE will be randomized so there is a 50% chance for either eye to
receive one treatment. Subjects will be seen on the day of surgery, post op day one, one
week, one month, three months, six months and one year. Subjects will receive topical
antibiotics in each eye for one week following the procedure. Subjects will receive topical
steroid ophthalmic drops for one week after treatment. Subjects will also receive topical
antibiotic ophthalmic drops for four days after treatment. All of this is within the usual
and customary standard of care for the treatment of subjects undergoing LASIK and SMILE
surgery.
Inclusion Criteria:
- Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters
and -8.00 diopters.
- Subjects with less than 0.75 diopters of astigmatism.
Exclusion Criteria:
- Subjects under the age of 22.
- Subjects with excessively thin corneas.
- Subjects with topographic evidence of keratoconus.
- Subjects with ectatic eye disorders.
- Subjects with autoimmune diseases.
- Subjects who are pregnant or nursing.
- Subjects must have similar levels of nearsightedness in each eye. They can not be more
than 1.5 diopter of difference between eyes.
- Subjects with 0.75 or more diopters of astigmatism
- Subjects must have similar levels of astigmatism in each eye. They can not have more
than 0.50 diopters of difference between eyes.
We found this trial at
1
site
Palo Alto, California 94303
Principal Investigator: Edward E Manche, MD
Phone: 650-498-7020
Click here to add this to my saved trials
