Recruiting NCT05486546
Contoura With Phorcides Compared to Wavefront Optimized LASIK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contoura with Phorcides, WaveLight Wavefront Optimized.
- Who it may be relevant to
- Registry conditions: Myopia, Astigmatism. Basic parameters: 21 years — 38 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Overview
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
Interventions
- Procedure Contoura with Phorcides
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine - Device WaveLight Wavefront Optimized
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
Primary outcome measures
- Post-Op UDVA [Time frame: 3 months post-op]
Secondary outcome measures (5)
- Post-OP BCVA [Time frame: 3 months post-op]
- Residual Refractive Error [Time frame: 3 months post-op]
- Low Contrast Visual Acuity [Time frame: 3 months post-op]
- Pre-op and post-op visual acuity [Time frame: 3 months post-op]
- Corrected Distance Visual Acuity [Time frame: 3 months post-op]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Vance Thompson Vison — Bozeman
- Vance Thompson Vision — Omaha
- Vance Thompson Vision — Fargo
- Vance Thompson Vision — Sioux Falls
Identifiers
NCT: NCT05486546 · AMPLIO