LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 21 - 60 |
Updated: | 4/6/2019 |
Start Date: | June 2011 |
End Date: | December 2020 |
A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser
The purpose of the study is to compare the results of LASIK surgery when using Alcon
Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided
excimer laser system in patients with nearsightedness with and without astigmatism.
Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided
excimer laser system 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 a wavefront-guided
excimer laser and which eye is treated with wavefront-optimized 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, post op day 4-7, one month, three months, six months and one
year. The patient will receive topical antibiotics in each eye for one week following the
procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after
treatment. All of this is within the usual and customary standard of care for the treatment
of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound
research design.
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 a wavefront-guided
excimer laser and which eye is treated with wavefront-optimized 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, post op day 4-7, one month, three months, six months and one
year. The patient will receive topical antibiotics in each eye for one week following the
procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after
treatment. All of this is within the usual and customary standard of care for the treatment
of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound
research design.
Inclusion Criteria:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism
of up to 3.50 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 with or without astigmatism in
each eye.
- They can not be more than 1.5 diopters of difference between eyes.
- Patients must have similar levels of astigmatism in each eye.
- They can not have more than 1.5 diopters of difference in nearsightedness or
astigmatism between their two eyes.
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