Refractive Errors
Conditions
Brief summary
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.
Detailed description
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms. The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.
Interventions
DEVICEPhorcides Analytical Engine
Surgery planning using the Phorcides analytical engine.
Sponsors
Science in Vision
Alcon Research
American Corneal Consultants
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Candidate for Contoura excimer laser vision correction * Gender: males and females. * Age: 20 or older * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures. * Good ocular health, with no pathology that compromises visual acuity (other than refractive error) * Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated * Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D * Desire good vision at distance in both eyes
Exclusion criteria
* Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.) * Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty) * Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * Desire for good uncorrected near vision in one or both eyes * Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial * Unsuitability for the trial, in the opinion of the investigator, for any reason * Pregnancy or desire to become pregnant during the trial * Intraoperative complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Refractive Cylinder | 3 months postop | Residual refractive cylinder in diopters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity | 3 months postop | Uncorrected visual acuity at distance (4-6m) |
| Residual Refractive Sphere | 3 months postop | Residual refractive spherical equivalent in diopters |
| Satisfaction and Vision | 3 months postop | A questionnaire related to visual quality and satisfaction after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phorcides Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine. | 70 |
| Phorcides Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine. | 140 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inclusion criterion not met | 3 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Phorcides |
|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 5.4 |
| Corrected distance VA | -.04 logMAR STANDARD_DEVIATION 0.04 |
| MRSE | -3.6 diopters STANDARD_DEVIATION 1.79 |
| Refractive cylinder | 0.54 diopters STANDARD_DEVIATION 0.49 |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 27 Participants |
| Uncorrected distance VA | .95 logMAR (log of min angle of resolution STANDARD_DEVIATION 0.33 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 1 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Residual Refractive Cylinder
Residual refractive cylinder in diopters
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phorcides | Residual Refractive Cylinder | 0.04 diopters | Standard Deviation 0.09 |
Secondary
Residual Refractive Sphere
Residual refractive spherical equivalent in diopters
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phorcides | Residual Refractive Sphere | 0.08 diopters | Standard Deviation 0.2 |
Secondary
Satisfaction and Vision
A questionnaire related to visual quality and satisfaction after surgery
Time frame: 3 months postop
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Phorcides | Satisfaction and Vision | Double vision | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Double vision | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Trouble driving at night | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Trouble driving at night | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Trouble reading | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Trouble reading | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Dryness | None to moderate | 63 Participants |
| Phorcides | Satisfaction and Vision | Dryness | Marked to severe | 2 Participants |
| Phorcides | Satisfaction and Vision | Foreign body sensation | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Foreign body sensation | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Fluctuation in vision | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Fluctuation in vision | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Glare | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Glare | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Halos | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Halos | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Light sensitivity | None to moderate | 63 Participants |
| Phorcides | Satisfaction and Vision | Light sensitivity | Marked to severe | 2 Participants |
| Phorcides | Satisfaction and Vision | Pain | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Pain | Marked to severe | 0 Participants |
| Phorcides | Satisfaction and Vision | Starbursts | None to moderate | 65 Participants |
| Phorcides | Satisfaction and Vision | Starbursts | Marked to severe | 0 Participants |
Secondary
Uncorrected Distance Visual Acuity
Uncorrected visual acuity at distance (4-6m)
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phorcides | Uncorrected Distance Visual Acuity | -.11 logMAR | Standard Deviation 0.06 |