Multi Laser Platform Comparison Study for LASIK

NCT00770094 | Unknown Phase 4

• 1 other identifier: VBLWL-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Myopia; Astigmatism

Keywords

LASIK; Laser Vision correction; Myopia; Myopia with astigmatism; Nearsighted

Outcome Measures

Primary Outcomes (1)

• Uncorrected visual acuity

  1 month post operative

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Device: Excimer Lasers

Group 2

ACTIVE COMPARATOR

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

Device: Excimer Laser for the LASIK procedure

Group 3

ACTIVE COMPARATOR

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

Device: Excimer Laser for LASIK

Interventions

Excimer Lasers DEVICE

WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System

Group 1

Excimer Laser for the LASIK procedure DEVICE

WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System

Also known as: LASIK

Group 2

Excimer Laser for LASIK DEVICE

WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System

Also known as: LASIK

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Durrie Vision: lead
• Alcon Research: collaborator

Study Sites (3)

Lasik Plus-Galleria

Atlanta, Georgia, 30339, United States

Location

Lasik Plus Edina

Edina, Minnesota, 55435, United States

Location

Lasik Plus-Tyson's Corner

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Lasers, Excimer; Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

US (3)