Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK

NCT00821236 | Completed Phase 4 Results

• 1 other identifier: WLCVLV-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare LASIK outcomes using the WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the LADARVision 4000 excimer laser treatment. Standard refractive outcomes such as uncorrected and best corrected visual acuity, and intended vs. achieved postoperative refractions will be evaluated; in addition, high order optical aberrations, contrast sensitivity, and topography will be measured.

Conditions

Myopia; Astigmatism

Keywords

Myopia; LASIK; Astigmatism; Laser Vision Correction; Excimer Laser

Outcome Measures

Primary Outcomes (3)

• 1 Day Postoperative Lasik Uncorrected Visual Acuity

  Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

  1 Day

• 1 Week Postoperative Lasik Uncorrected Visual Acuity

  Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

  1 week post op

• 1 Month Postoperative Lasik Visual Acuity

  Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

  1 Month Postoperative

Study Arms (3)

Wavelight

ACTIVE COMPARATOR

WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment

Device: Excimer Laser

AMO/VISX CustomVue

ACTIVE COMPARATOR

AMO/VISX CustomVue™

Device: AMO/VISX CustomVue™

LADARVision 4000 excimer laser

ACTIVE COMPARATOR

LADARVision 4000 excimer laser

Device: LADARVision 4000 excimer laser

Interventions

Excimer Laser DEVICE

WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment

Wavelight

AMO/VISX CustomVue™ DEVICE

Excimer Laser

AMO/VISX CustomVue

LADARVision 4000 excimer laser DEVICE

Excimer Laser

LADARVision 4000 excimer laser

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. 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 twelve 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.
• 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, 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 Intraocular pressure\>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 (2)

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Karl G. Stonecipher, MD

Greensboro, North Carolina, 27410, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Brigette Ellis
• Organization: Durrie Vision

bellis@durrievision.com

913-491-3330

Study Officials

• Daniel S. Durrie, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 1, 2013
• Results First Posted: March 1, 2013

Record last verified: 2013-01

Locations

US (2)