Myopia, Astigmatism
Conditions
Keywords
Myopia, LASIK, Astigmatism, Laser Vision Correction, Excimer Laser
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.
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 .
Interventions
DEVICEExcimer Laser
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
DEVICEAMO/VISX CustomVue™
Excimer Laser
DEVICELADARVision 4000 excimer laser
Excimer Laser
Sponsors
Alcon Research
Durrie Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wavelight WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment | 20 |
| AMO/VISX CustomVue AMO/VISX CustomVue™ | 10 |
| LADARVision 4000 Excimer Laser LADARVision 4000 excimer laser treatment | 10 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Total | Wavelight | AMO/VISX CustomVue | LADARVision 4000 Excimer Laser |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 20 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 25 Participants | 13 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wavelight | 1 Day Postoperative Lasik Uncorrected Visual Acuity | -0.04 LogMar | Standard Deviation 0.08 |
| AMO/VISX CustomVue | 1 Day Postoperative Lasik Uncorrected Visual Acuity | -0.05 LogMar | Standard Deviation 0.06 |
| LADARVision 4000 Excimer Laser | 1 Day Postoperative Lasik Uncorrected Visual Acuity | 0.06 LogMar | Standard Deviation 0.16 |
Primary
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.
Time frame: 1 Month Postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wavelight | 1 Month Postoperative Lasik Visual Acuity | -0.1 LogMar | Standard Deviation 0.09 |
| AMO/VISX CustomVue | 1 Month Postoperative Lasik Visual Acuity | -0.11 LogMar | Standard Deviation 0.06 |
| LADARVision 4000 Excimer Laser | 1 Month Postoperative Lasik Visual Acuity | 0.08 LogMar | Standard Deviation -0.08 |
Primary
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.
Time frame: 1 week post op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wavelight | 1 Week Postoperative Lasik Uncorrected Visual Acuity | -0.04 LogMar | Standard Deviation 5.27 |
| AMO/VISX CustomVue | 1 Week Postoperative Lasik Uncorrected Visual Acuity | -0.09 LogMar | Standard Deviation 2.36 |
| LADARVision 4000 Excimer Laser | 1 Week Postoperative Lasik Uncorrected Visual Acuity | -0.02 LogMar | Standard Deviation 5.8 |