NCT05486546RecruitingNot Applicable
Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Daniel Terveen6 sites in 1 country120 target enrollmentStarted: August 15, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- Post-Op UDVA
Study Overview
Brief Summary
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 38 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Post-Op UDVA
Time Frame: 3 months post-op
Percent of participants with monocular UDVA of 20/16 or better
Secondary Outcomes
- Pre-op and post-op visual acuity(3 months post-op)
- Corrected Distance Visual Acuity(3 months post-op)
- Low Contrast Visual Acuity(3 months post-op)
- Post-OP BCVA(3 months post-op)
- Residual Refractive Error(3 months post-op)
Investigators
Daniel Terveen
Principal Investigator
Vance Thompson Vision
Study Sites (6)
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