The FDA has approved a new indication for the Star S4 IR Excimer Laser System and iDesign System. With the approval, the iDesign can be used for LASIK patients with hyperopia, with and without astigmatism.
In addition to myopia and mixed astigmatism, physicians can now treat hyperopia over a wide range of pupil sizes in patients who are 18 years and older. Capturing five different measurements in a single capture sequence – wavefront aberrometry, wavefront refraction, corneal topography, keratometry, and pupillometry – the iDesign System can help save time during the procedure.
“With its five-measurement capture sequence and high-definition sensor, the iDesign System creates an individualized treatment plan for each patient," Jay Pepose, MD, said in a Johnson & Johnson Vision news release. “It’s now capable of treatment for a wider spectrum of patients who may have myopia, mixed astigmatism, or hyperopia. This broad range of treatment in one system will now offer more solutions to more patients.”
Dr. Pepose served as a medical investigator for the clinical trial.
The new indication is for wavefront-guided LASIK for use in patients:
- With hyperopia with and without astigmatism as measured by the iDesign System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;
- With agreement between manifest refraction (adjusted for optical infinity) and the iDesign System refraction as follows:
- Spherical Equivalent: Magnitude of the difference is less than 0.625 D;
- Cylinder: Magnitude of the difference is less than or equal to 0.5 D;
- 18 years of age or olderWith refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery)