High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

Stanford University100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Nearsightedness Astigmatism

Interventions

LASIKPROCEDURE

WFG vs. WFO LASIK

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Uncorrected visual acuity

Time frame: Twelve months

Secondary Outcomes

Quality of vision and quality of life using the QoV questionnaire

Time frame: One month, three months, six months and twelve months

Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)

Time frame: One day, one month, three months, six months and twelve months

Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)

Time frame: One, three, six and twelve months

Change in best spectacle corrected visual acuity

Time frame: One, three, six and twelve months

Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success

Time frame: One, three six and twelve months

Data from ClinicalTrials.gov

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