Trials / Completed
CompletedNCT04495829
Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (actual)
- Sponsor
- American Corneal Consultants · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
Summary
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.
Detailed description
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms. The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Phorcides Analytical Engine | Surgery planning using the Phorcides analytical engine. |
Timeline
- Start date
- 2020-07-24
- Primary completion
- 2021-04-21
- Completion
- 2021-04-21
- First posted
- 2020-08-03
- Last updated
- 2023-07-20
- Results posted
- 2022-04-14
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04495829. Inclusion in this directory is not an endorsement.