Contoura With Phorcides Compared to Wavefront Optimized LASIK
NCT ID: NCT05486546
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-08-15
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study: Phorcides
Contoura with Phorcides used for surgical planning of LASIK procedure
Contoura with Phorcides
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
Control: Wavefront Optimized
WaveLight Wavefront Optimized used for surgical planning of LASIK procedure
WaveLight Wavefront Optimized
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
Interventions
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Contoura with Phorcides
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
WaveLight Wavefront Optimized
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
38 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Daniel Terveen
OTHER
Responsible Party
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Daniel Terveen
Principal Investigator
Locations
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Vance Thompson Vison
Bozeman, Montana, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Vance Thompson Vision
Fargo, North Dakota, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AMPLIO
Identifier Type: -
Identifier Source: org_study_id
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