Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT05848817 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Contoura LASIK (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mann Eye Institute
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Satisfaction |
50 | — |
| SECONDARY Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D |
90 | — |
Summary
Eligibility Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
- Appropriate candidate for uncomplicated bilateral LASIK surgery
- Gender: Males and Females.
- Age: 21 to 39 years of age.
- Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.
- If currently wearing contact lenses:
- Soft CTL wearers discontinue for minimum 3 days
- RGP CTL wearers discontinue for 1 month per decade of wear
- Stable refraction (2 consecutive manifest refractions within 0.25 SE)
- Stable K readings (2 consecutive K readings in 2 consecutive visits)
- Residual bed thickness 250um or greater
- Willing and able to comply with scheduled visits and other study procedures.
- Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Subjects with history of previous ocular surgery.
- Subjects with topographic evidence of keratoconus, or ectasia.
- Subjects with autoimmune diseases.
- Subjects who are pregnant or nursing.
- Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
- Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive 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.
Data sourced from ClinicalTrials.gov (NCT05848817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.