Trials / Unknown
UnknownNCT04545073
Outcomes of a Trifocal IOL in Post-refractive Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Vance Thompson Vision ND · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
Detailed description
The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PanOptix | Trifocal IOL with ORA in post refractive patients |
Timeline
- Start date
- 2020-10-09
- Primary completion
- 2021-03-01
- Completion
- 2021-05-01
- First posted
- 2020-09-10
- Last updated
- 2020-10-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04545073. Inclusion in this directory is not an endorsement.