High Resolution Wavefront-guided vs. Wavefront Optimized LASIK
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 3/9/2019 |
| Start Date: | October 2015 |
| End Date: | January 2021 |
A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
The investigators are comparing outcomes of LASIK surgery using a high definition
wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with
and without astigmatism.
wavefront-guided laser to a wavefront-optimized 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 the investigators 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
CustomVue and which eye is treated with Wavelight 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. 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 investigators 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
CustomVue and which eye is treated with Wavelight 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.
Inclusion criteria.
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism
of up to 5.00 diopters.
Exclusion criteria.
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness and farsightedness in each eye.
They can not be more than 1.5 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more
than 1.5 diopter of difference between eyes.
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