Clinical trial NCT05486546: Contoura With Phorcides Compared to Wavefront Optimized LASIK
Official title: Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: Visual acuity
Refractive outcome
LASIK
Contrast sensitivity
Wavefront Optimized
Topography-guided
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Post-Op UDVA
timeFrame: 3 months post-op
Secondary outcomes:
measure: Post-OP BCVA
timeFrame: 3 months post-op
measure: Residual Refractive Error
timeFrame: 3 months post-op
measure: Low Contrast Visual Acuity
timeFrame: 3 months post-op
measure: Pre-op and post-op visual acuity
timeFrame: 3 months post-op
measure: Corrected Distance Visual Acuity
timeFrame: 3 months post-op
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Vance Thompson Vison
state: Montana
city: Omaha
country: United States
facility: Vance Thompson Vision
state: Nebraska
city: Fargo
country: United States
facility: Vance Thompson Vision
state: North Dakota
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References: