A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C

Inclusion Criteria: Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye. Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye. Patientshave a corneal thickness greater than or equal to 500 microns in the non-dominant eye. Patients have corrected distance and near visual acuity of 20/25 or better in each eye. Patients have distance corrected near visual acuity of 20/40 or worse in each eye. Patients are willing and able to sign and understand a written Informed Consent Form priorto any study-specific procedures. Patients are willing and able to return for scheduled follow-up examinations for 24 monthsafter the corneal inlay surgery.

Exclusion Criteria: Patients with prior ocular surgery. Patients with clinically significant dry eye (i.e.,significant diffuse punctate staining with fluorescein and a tear breakup time less than 8s) in either eye. Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)). Patients with macular pathology based on dilated fundus exam and/or optical coherencetomography (OCT) image. Patients who would be co-managed by an ophthalmologist or optometrist who is not approvedas a ReVision Optics investigator. Patients with ocular pathology or disease (including pupil pathology such as fixatedpupils) that might confound the outcome or increase the risk of adverse event. Patients taking systemic or topical medications that might confound the outcome or increasethe risk of adverse event. Patients taking isotretinoin or amiodarone hydrochloride and anyother medication that affects the tear film or accommodation, including but not limited to,mydriatic, cycloplegic and mitotic agents, tricyclic, phenothiazines, benzodiazepines, andfirst generation antihistamines. Patients with known sensitivity to any planned study medications. Patients with residual,recurrent, active or uncontrolled eyelid disease. Patients with significant cornealasymmetry or irregular topography. Patients with clinically significant anterior segmentpathology. Patients with any corneal abnormality, including but not limited to, slit lampfindings for corneal staining Grade 3 or higher, recurrent corneal erosion or severebasement membrane disease, and pterygium extending onto the cornea. Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconussuspect. Patients with history of Herpes zoster or Herpes simplex keratitis. Patients with anyprogressive retinal disease or subjects with a history or evidence of retinal vascularocclusion and/or hypercoagulability, because of the risks associated with high pressuresduring suction application. Patients with known history of steroid-responsive intraocular pressure increases, glaucoma,preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma. Patients with amblyopia or strabismus or those who are at risk for developing strabismuspostoperatively as determined by corneal light reflex and cover-uncover testing. Patients with diabetic retinopathy, collagen, vascular, diagnosed autoimmune disease (e.g.,lupus, rheumatoid arthritis, fibromylagia), immunodeficiency (e.g., HIV), connective tissuedisease, or clinically significant atopic syndrome such as allergies or asthma. Patients on chronic systemic corticosteroid or other immunosuppressive therapy that mayaffect wound healing. Patients with any type of active cancer (ophthalmic or non-ophthalmic). Patients withuncontrolled infections of any kind. Patients who are pregnant, lactating, of child-bearingpotential and not practicing a medically approved method of birth control, or planning tobecome pregnant during the course of the trial, and patients with other conditionsassociated with fluctuation of hormones that could lead to refractive changes. Patients who actively participate in contact sports (i.e., boxing, martial arts) whereimpacts to the face and eye are a normal occurrence. Patients participating in any other ophthalmic or non-ophthalmic drug/device clinicaltrials during the time of this clinical investigation.