![]() ![]() Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated.Ĥ. ![]() Subjects with anterior segment pathology in either eye.ģ. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or multifocal intraocular lenses (IOLs) in either eye.Ģ. Subjects must have a clear or open posterior capsule in the non-dominant eye.No change in MRSE greater than ± 0.50 D within the last 2 consecutive visits at least 2 months apart) in the non-dominant eye. Subjects must be able to demonstrate refractive stability after cataract surgery (e.g.Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.Subjects must have documented monovision tolerance.Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the non-dominant eye.Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.Subjects must have a central corneal thickness of between 500 and 600 microns in the non-dominant eye.Subjects must have a tear break-up time (TBUT) of ≥8 seconds.Subjects must have a manifest refraction spherical equivalent (MRSE) between - 0.50 and +1.00 D with no more than 0.75 D of refractive cylinder in the non- dominant eye.Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.Subjects must have an uncorrected distance visual acuity of 20/25 or better in both eyes.Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.Subjects must provide informed consent, have signed the written informed consent form, and been given a copy.This technology may also demonstrate potential clinical utility in bilateral pseudophakic subjects. The Raindrop Near Vision Inlay is expected to provide low induction of visual symptoms and improvement of near and intermediate vision in emmetropic subjects with presbyopia. The inlay is placed in the non-dominant eye, centered over the pupil after a corneal flap (LASIK) has been made. ![]() The inlay is the same refractive index as the human cornea. ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and intermediate vision. And, successful monovision is generally limited to patients with a history of successful use of contact lenses for monovision, and even in these eyes, monovision is associated with a substantial decrease in stereo acuity and contrast sensitivity. Multifocal contact lenses suffer from visual symptoms and instability due to potential rotation and movement of the contact lenses on the surface of the cornea. For example, reading glasses can easily be lost or not conveniently available. All these options suffer limitations from the patient perspective. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact lenses, or monovision LASIK, which allows the patient to see near objects. Presbyopia is a natural outcome of pseudophakic subjects with monofocal or toric intraocular lenses. Why Should I Register and Submit Results?.
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