Astigmatism, Myopia
Conditions
Keywords
Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided
Brief summary
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
Interventions
PROCEDUREContoura with Phorcides
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
DEVICEWaveLight Wavefront Optimized
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
Sponsors
Alcon Research
Daniel Terveen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Patients at least age 21 years of age undergoing LASIK eye surgery * Willing and able to comprehend informed consent and complete 1 month post-op visit * Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion * Candidates for Contoura with Phorcides (Myopic, astigmatism \<3.0D) * Both eyes targeted for plano * Pre-operative total corneal Pachymetry 490um or above * Stable refractive error \<0.50D change in preceding year * Good general and ocular health * Pre-operative exam completed within three months of surgery * SCL discontinued 3 days prior to pre-op exam and the procedure * Pachymetry above 490 with residual greater than 270um * Candidates who, as determined by the investigator, can safely undergo LASIK
Exclusion criteria
* Patients under 21 years of age * Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon * Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes) * Pachymetry below 490 * Autoimmune or immunodeficiency diseases * Pregnant or nursing women * Patients with signs of inability to understand consent for study and procedure planned * Patients with history of previous ocular surgery * Patients with strabismus or amblyopia * Patients that have a BCDVA of 20/25 or worse in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Op UDVA | 3 months post-op | Percent of participants with monocular UDVA of 20/16 or better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Refractive Error | 3 months post-op | Residual astigmatism and residual SE |
| Low Contrast Visual Acuity | 3 months post-op | 25% low contrast visual acuity post-op |
| Pre-op and post-op visual acuity | 3 months post-op | Percent of participants with post-op UDVA equal to or better than their pre-op CDVA |
| Corrected Distance Visual Acuity | 3 months post-op | Compare percent of participants with post-operative and pre-operative CDVA |
| Post-OP BCVA | 3 months post-op | Percent of participants with monocular and binocular BCVA of 20/16 or better |
Countries
United States
Contacts
Primary ContactDaniel Terveen, MD
Backup ContactElise Meide, M.S.
Outcome results
None listed