Wavefront-guided PRK vs Wavefront-optimized PRK
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 4/26/2018 |
| Start Date: | March 2014 |
| End Date: | December 2019 |
A Prospective, Randomized Comparison of Fellow Eyes Undergoing Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser
The purpose of the study is to compare the results of PRKK surgery when using
wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser
treatment in patients with nearsightedness with and without astigmatism
wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser
treatment in patients with nearsightedness with and without astigmatism
This is a research study comparing the outcomes of PRK surgery for nearsightedness when using
the two different excimer laser technologies. Patients will have both eyes treated with the
Alcon WaveLight Allegretto excimer laser. You will be one of 50 sighted patients at Stanford
to undergo treatment in this clinical research trial. This will be a prospective, randomized,
research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo
refractive keratectomy (PRK) using one laser technology in the first eye and the second laser
technology in the fellow eye for the correction of myopia (nearsightedness) with or without
astigmatism will be enrolled. The choice of which eye receives the wavefront guided
technology and which eye receives the wavefront-optimized technology will be randomized prior
to enrollment. Randomization will be done according to a randomization schedule. You will not
know which eye is being treated with which each technology. The randomization will determine
only whether your right or left eye is treated with the wavefront guided technology. The
other eye will be treated with wavefront-optimized laser technology. You have a fifty percent
chance of having your left eye treated with custom wavefront guided technology as your right
eye. Subjects will undergo bilateral (both eyes at once) PRK treatments using the Alcon
WaveLight Allegretto excimer laser. All subjects will be followed for one year after the
vision correction procedure. Subjects scheduled to undergo PRK for the correction of myopia
(nearsightedness) with or without astigmatism will be screened for eligibility. Eligible
subjects will be examined preoperatively to establish a baseline for ocular condition (the
general health and glasses prescription of the eyes). Postoperatively, subjects will undergo
an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this
protocol. Patients will complete questionnaires preoperatively and postoperatively evaluating
quality of vision and quality of life. Retreatments (a second operation on the same eye for
residual nearsightedness) will not be allowed during the first twelve months of this study.
If you elect to undergo a retreatment of your PRK surgery prior to the 12-month
post-operative visit, the retreated eye will be exited from the study as of the retreatment
date.
Any significant new finding developed during the course of the research which may relate to
the subject's willingness to continue participation will be provided to the subject or
subject's representative in a timely manner.
the two different excimer laser technologies. Patients will have both eyes treated with the
Alcon WaveLight Allegretto excimer laser. You will be one of 50 sighted patients at Stanford
to undergo treatment in this clinical research trial. This will be a prospective, randomized,
research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo
refractive keratectomy (PRK) using one laser technology in the first eye and the second laser
technology in the fellow eye for the correction of myopia (nearsightedness) with or without
astigmatism will be enrolled. The choice of which eye receives the wavefront guided
technology and which eye receives the wavefront-optimized technology will be randomized prior
to enrollment. Randomization will be done according to a randomization schedule. You will not
know which eye is being treated with which each technology. The randomization will determine
only whether your right or left eye is treated with the wavefront guided technology. The
other eye will be treated with wavefront-optimized laser technology. You have a fifty percent
chance of having your left eye treated with custom wavefront guided technology as your right
eye. Subjects will undergo bilateral (both eyes at once) PRK treatments using the Alcon
WaveLight Allegretto excimer laser. All subjects will be followed for one year after the
vision correction procedure. Subjects scheduled to undergo PRK for the correction of myopia
(nearsightedness) with or without astigmatism will be screened for eligibility. Eligible
subjects will be examined preoperatively to establish a baseline for ocular condition (the
general health and glasses prescription of the eyes). Postoperatively, subjects will undergo
an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this
protocol. Patients will complete questionnaires preoperatively and postoperatively evaluating
quality of vision and quality of life. Retreatments (a second operation on the same eye for
residual nearsightedness) will not be allowed during the first twelve months of this study.
If you elect to undergo a retreatment of your PRK surgery prior to the 12-month
post-operative visit, the retreated eye will be exited from the study as of the retreatment
date.
Any significant new finding developed during the course of the research which may relate to
the subject's willingness to continue participation will be provided to the subject or
subject's representative in a timely manner.
Inclusion Criteria:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -8.00 diopters with or without astigmatism
of up to 5.00 diopters.
Exclusion Criteria:
- Subjects under the age of 21.
- Excessively thin corneas.
- Topographic evidence of keratoconus.
- Ectactic eye disorders.
- Autoimmune diseases.
- Pregnant or nursing.
- Patients must have similar levels of nearsightedness in each eye. They can not be more
than 2.5 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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