Multi Laser Platform Comparison Study for LASIK (VBLWL-001)

Durrie Vision

Status and phase: Unknown; Phase 4

Conditions: Myopia; Astigmatism

Treatments: Device: Excimer Lasers; Device: Excimer Laser for the LASIK procedure; Device: Excimer Laser for LASIK

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00770094

VBLWL-001

Details and patient eligibility

About

Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms.

Full description

This will be a prospective, randomized, multicenter clinical trial in which up to 180 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) for the correction of myopia with or without astigmatism will be enrolled. Enrolled subjects will have a different Excimer laser system performed in each eye. There will be 30 subjects (60 eyes) in each group.

Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who have up to -7.00D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in both eyes.
• Subjects must have a stable refraction as documented by previous clinical records or clinical history. Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to the baseline examination in both eyes or as documented by clinical judgment by the investigator.
• Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye.
• Subjects must have visual acuity correctable to at least 20/20 in both eyes.
• Subjects must be at least 18 years of age.
• Subjects must be willing and able to return for scheduled follow up examinations for three months after LASIK surgery.
• Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

• Subjects for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
• Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively in either eye.
• Eyes for which the baseline standard manifest refraction exhibits greater than 1.00D more minus in sphere power, or a difference of greater than 0.75 D in cylinder power between eyes.
• Subjects desiring spherical under correction in one eye (i.e. no monovision correction is permitted).
• Subjects for whom the preoperative assessment of the ocular topography and /or aberrations indicates that either eye is not a suitable candidate for LASIK vision correction procedure. Examples include frank or forme frust keratoconus, corneal warpage, and pellucid marginal degeneration, etc.
• Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
• Subjects with anterior segment pathology, including clinically significant cataracts or corneal scarring or neovascularization in either eye.
• Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (specifically, recurrent corneal erosion, severe basement membrane disease) in either eye.
• Subjects with ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye.
• Subjects with unstable (distorted/not clear) corneal mires on central keratometry in either eye.
• Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
• Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
• Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or diabetes.
• Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>23 mm Hg in either eye.
• Subjects with macular pathology in either eye.
• Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
• Subjects with known sensitivity to planned study concomitant medications.
• Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group 1

Active Comparator group

Description:

WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye

Treatment:

Device: Excimer Lasers

Group 2

Active Comparator group

Description:

WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye

Treatment:

Device: Excimer Laser for the LASIK procedure

Group 3

Active Comparator group

Description:

WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye

Treatment:

Device: Excimer Laser for LASIK