Clinical trial NCT02565537: High Resolution Wavefront-guided vs. Wavefront Optimized LASIK
Official title: A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nearsightedness
Astigmatism
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uncorrected visual acuity
timeFrame: Twelve months
Secondary outcomes:
measure: Quality of vision and quality of life using the QoV questionnaire
timeFrame: One month, three months, six months and twelve months
measure: Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)
timeFrame: One day, one month, three months, six months and twelve months
measure: Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)
timeFrame: One, three, six and twelve months
measure: Change in best spectacle corrected visual acuity
timeFrame: One, three, six and twelve months
measure: Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success
timeFrame: One, three six and twelve months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Edward E. Manche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.