The Food and Drug Administration (FDA) has approved Revision Optics’ Raindrop Near Vision Inlay, a corneal implant to improve near vision in certain patients with presbyopia. This marks the second implantable corneal device approved to correct near vision in patients who have not had cataract surgery, and the first implantable device that changes the shape of the cornea to achieve improved sight. 

The Raindrop Near Vision Inlay is made of a hydrogel material and looks like a tiny contact lens smaller than the eye of a needle. This device is intended for use in patients aged 41–65 years who are unable to focus clearly on near objects or small print and need reading glasses with +1.50 or +2.50 diopters of power, but do not require glasses or contacts for clear distance vision. 

The device is implanted by an eye surgeon who creates a flap in the cornea of the patient’s non-dominant eye. The inlay creates a steeper surface that can help the eye focus on near objects or print. As the curvature of the cornea is reshaped with the inlay, the refractive error causing near vision difficulties is corrected. 

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The safety and efficacy of Raindrop Near Vision Inlay were evaluated in a clinical study (n=373) of patients who were implanted with the device. Two years post-implantation, 92% of patients in the analysis were able to see with 20/40 vision or better at near distances with the eye containing the implant. The implant is not recommended for patients who:

  • have severe dry eye or an active eye infection or inflammation
  • exhibit signs of corneal disease characterized by keratoconus
  • have abnormal features of the cornea to be implanted
  • have certain autoimmune or connective tissue diseases
  • do not have enough corneal thickness to withstand the procedure
  • have recent eye infection or problems resulting from a previous infection
  • have uncontrolled glaucoma or uncontrolled diabetes

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