WLCVLV-001: Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK

• Sponsor: Durrie Vision (Other)
• Overall Status: Completed
• CT.gov ID: NCT00821236
• Collaborator: Alcon Research (Industry)
• Enrollment: 40
• Locations: 2
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 20
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Device: Excimer Laser; Device: AMO/VISX CustomVue™; Device: LADARVision 4000 excimer laser	Phase 4

Detailed Description

The primary objective of this study is to compare WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the LADARVision 4000 excimer laser treatment using both subjective and objective outcome measures. This comparison will be made between fellow eyes of the same patient following excimer laser ablation using the WaveLight ALLEGRETTO WAVE™ Excimer Laser System in one eye and the AMO/VISX CustomVue™ or the LADARVision 4000 excimer laser in the contralateral eye .

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi Center Clinical Comparison of Fellow Eyes Undergoing Lasik Using the Wavelight Allegretto Wave™ Excimer Laser in One Eye and the Amo/Visx Customvue™ or the Ladarvision 4000 Excimer Laser System in the Contralateral Eye
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Wavelight WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	Device: Excimer Laser; WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
Active Comparator: AMO/VISX CustomVue AMO/VISX CustomVue™	Device: AMO/VISX CustomVue™; Excimer Laser
Active Comparator: LADARVision 4000 excimer laser LADARVision 4000 excimer laser	Device: LADARVision 4000 excimer laser; Excimer Laser

Outcome Measures

Primary Outcome Measures

1. 1 Day Postoperative Lasik Uncorrected Visual Acuity [1 Day]

   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.

2. 1 Week Postoperative Lasik Uncorrected Visual Acuity [1 week post op]

   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.

3. 1 Month Postoperative Lasik Visual Acuity [1 Month Postoperative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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. 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.

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.

• 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.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durrie Vision	Overland Park	Kansas	United States	66211
2	Karl G. Stonecipher, MD	Greensboro	North Carolina	United States	27410

Sponsors and Collaborators

• Durrie Vision
• Alcon Research

Investigators

• Principal Investigator: Daniel S. Durrie, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel S. Durrie, MD, President, Durrie Vision
• ClinicalTrials.gov Identifier: NCT00821236
• Other Study ID Numbers: WLCVLV-001
• First Posted: Jan 13, 2009
• Last Update Posted: Mar 1, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Daniel S. Durrie, MD, President, Durrie Vision: Myopia; LASIK; Astigmatism; Laser Vision Correction; Excimer Laser
• Additional relevant MeSH terms: Myopia; Astigmatism

Study Results

Participant Flow

Arm/Group Title	Lasik for Treatment of Nearsightedness
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
Period Title: Overall Study
STARTED	40
COMPLETED	37
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Wavelight	AMO/VISX CustomVue	LADARVision 4000 Excimer Laser	Total
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue™	LADARVision 4000 excimer laser treatment	Total of all reporting groups
Overall Participants	20	10	10	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	10 100%	10 100%	40 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	13 65%	6 60%	6 60%	25 62.5%
Male	7 35%	4 40%	4 40%	15 37.5%

Outcome Measures

1. Primary Outcome

Title	1 Day Postoperative Lasik Uncorrected Visual Acuity
Description	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.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wavelight	AMO/VISX CustomVue	LADARVision 4000 Excimer Laser
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue™	LADARVision 4000 excimer laser treatment
Measure Participants	20	10	10
Mean (Standard Deviation) [LogMar]	-0.04 (0.08)	-0.05 (0.06)	0.06 (0.16)

2. Primary Outcome

Title	1 Week Postoperative Lasik Uncorrected Visual Acuity
Description	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.
Time Frame	1 week post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wavelight	AMO/VISX CustomVue	LADARVision 4000 Excimer Laser
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue™	LADARVision 4000 excimer laser treatment
Measure Participants	20	10	10
Mean (Standard Deviation) [LogMar]	-0.04 (5.27)	-0.09 (2.36)	-0.02 (5.8)

3. Primary Outcome

Title	1 Month Postoperative Lasik Visual Acuity
Description	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.
Time Frame	1 Month Postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wavelight	AMO/VISX CustomVue	LADARVision 4000 Excimer Laser
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue™	LADARVision 4000 excimer laser treatment
Measure Participants	20	10	10
Mean (Standard Deviation) [LogMar]	-0.1 (0.09)	-0.11 (0.06)	0.08 (-0.08)

Adverse Events

Arm/Group Title	Wavelight		AMO/VISX CustomVue		LADARVision 4000 Excimer Laser
Arm/Group Description	WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment		AMO/VISX CustomVue™		LADARVision 4000 excimer laser treatment
All Cause Mortality
	Wavelight		AMO/VISX CustomVue		LADARVision 4000 Excimer Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Wavelight		AMO/VISX CustomVue		LADARVision 4000 Excimer Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Wavelight		AMO/VISX CustomVue		LADARVision 4000 Excimer Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.