NCT05486546 · Daniel Terveen
Contoura With Phorcides Compared to Wavefront Optimized LASIK
What this study is about
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
View original scientific description
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
Percent of participants with monocular UDVA of 20/16 or better
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bozeman, Montana
- Omaha, Nebraska
- Fargo, North Dakota
- Sioux Falls, South Dakota
Collaborators
Alcon Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 26, 2023 · Source of record for eligibility and locations