Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism

Bismarck Lasik

Status

Terminated

Conditions

Myopia

Astigmatism

Treatments

Device: Contoura LASIK with Phorcides planning strategy

Device: Contoura LASIK with manifest refraction planning strategy

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05888337

SW-23-01

Details and patient eligibility

About

The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.

Full description

This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years old and above
Preoperative total corneal Pachymetry 490um or above
BCVA 20/20 or better
Stable refractive error <0.50D MRSE change in preceding year
Good general and ocular health
Preoperative exam completed within three months of surgery
Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
Residual stromal bed greater than 270um
Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
Candidates who elect to target both eyes targeted for emmetropia
≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees

Exclusion criteria

Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
Pachymetry below 490
Autoimmune or immunodeficiency diseases, Pregnant or nursing women
Subjects with signs of inability to understand consent for study and procedure planned
Subjects with history of previous ocular surgery

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.