FDA Approves iDesign Studio System to Treat Mixed Astigmatism

Source: Abbott Medical Optics

Tuesday, January 10, 2017 | FDA Approval/Clearance , Abbott Medical Optics, AMO


The FDA has approved Abbott’s Star S4 IR excimer laser system and iDesign Advanced WaveScan Studio System for use in LASIK patients with mixed astigmatism.

In a clinical study on 149 eyes treated using the iDesign System, 91.9% of all eyes achieved uncorrected visual acuity (UCVA) of 20/20 or better vision without glasses at 3 months postoperative. The clinical study also demonstrated early refractive stability for patients at 3 months postoperative and no adjustments were needed for the complex correction, proving an accurate algorithm from the iDESIGN System.

“Doctors can map the entire visual path with precision and capture a distinct resolution of the eye with Abbott’s iDesign System. This data helps determine an effective treatment plan for a complicated refractive condition,” Robert Maloney, MD, who served as a medical investigator for the clinical trial, said in a company news release. “More people are now eligible for LASIK to treat this challenging form of refractive error for people with mixed astigmatism – they typically have had limited options in the past.”

Mixed astigmatism patients require a more complex ablation plan compared to those with simple myopia or hyperopia as it requires the cornea to be flattened in one meridian and steepened in the opposite meridian to effectively eliminate the refractive error while removing as little corneal tissue as possible. The iDesign System acts as the "brain" of the procedure, generating a high-definition scan that measures and maps irregularity of the eye that may impact vision. From these measurements, the system creates an accurate and personalized treatment plan based on the unique blueprint of each person’s eyes. In addition to nearsightedness, doctors can now treat mixed astigmatism over a wide range of pupil sizes, and those who are 18 years of age and older.

This new indication is for wavefront-guided laser assisted in situ keratomileusis (LASIK) for use in patients:
    •    With mixed astigmatism as measured by the iDesign System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
    •    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 older, and
    •    with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery)

 


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