Contoura With Phorcides Compared to Wavefront Optimized LASIK

Daniel Terveen

Status: Enrolling

Conditions: Myopia; Astigmatism

Treatments: Device: WaveLight Wavefront Optimized; Procedure: Contoura with Phorcides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05486546

AMPLIO

Details and patient eligibility

About

Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Study: Phorcides

Experimental group

Description:

Contoura with Phorcides used for surgical planning of LASIK procedure

Treatment:

Procedure: Contoura with Phorcides

Control: Wavefront Optimized

Active Comparator group

Description:

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Treatment:

Device: WaveLight Wavefront Optimized