Last updated: April 24, 2023
Sponsor: Daniel Terveen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Astigmatism
Myopia
Treatment
N/AClinical Study ID
NCT05486546
AMPLIO
Ages 21-38 All Genders
Study Summary
Eligibility Criteria
Inclusion
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'smedical 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
Exclusion Criteria:
- Patients under 21 years of age
- Concomitant ocular condition which would limit the BCVA at the discretion of thesurgeon
- 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, uncontrolledDiabetes, 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
Total Participants: 120
Study Start date:
August 15, 2022
Estimated Completion Date:
December 01, 2023
Connect with a study center
Vance Thompson Vison
Bozeman, Montana 57105
United StatesActive - Recruiting
Vance Thompson Vision
Omaha, Nebraska 57105
United StatesActive - Recruiting
Vance Thompson Vision
Fargo, North Dakota 57105
United StatesActive - Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota 57108
United StatesActive - Recruiting
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