Contoura With Phorcides Compared to Wavefront Optimized LASIK

Not Applicable

Recruiting

• Conditions: Myopia; Astigmatism
• Interventions: Device: WaveLight Wavefront Optimized; Procedure: Contoura with Phorcides

• Registration Number: NCT05486546
• Lead Sponsor: Daniel Terveen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Study Start: 2022-08-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Wavefront Optimized	WaveLight Wavefront Optimized	WaveLight Wavefront Optimized used for surgical planning of LASIK procedure
Study: Phorcides	Contoura with Phorcides	Contoura with Phorcides used for surgical planning of LASIK procedure

Primary Outcome Measures

Name	Time	Method
Post-Op UDVA	3 months post-op	Percent of participants with monocular UDVA of 20/16 or better

Secondary Outcome Measures

Name	Time	Method
Corrected Distance Visual Acuity	3 months post-op	Compare percent of participants with post-operative and pre-operative CDVA
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
Post-OP BCVA	3 months post-op	Percent of participants with monocular and binocular BCVA of 20/16 or better
Residual Refractive Error	3 months post-op	Residual astigmatism and residual SE

Trial Locations

Locations (2)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Vance Thompson Vison; 🇺🇸 Bozeman, Montana, United States