A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.

4.3.1 Patients with prior corneal surgery including LASIK surgery in the non-dominant eye. (Not including Astigmatic Keratotomy or Limbal Relaxing Incisions)

4.3.2 Patients with clinically significant dry eye (i.e., significant diffuse punctate staining with fluorescein and a tear breakup time less than 8 s) in either eye.

4.3.3 Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).

4.3.4 Patients with clinically significant macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.

4.3.5 Patients who would be co-managed by an ophthalmologist or optometrist who is not an approved sub-investigator.

4.3.6 Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event in the investigator's opinion.

4.3.7 Patients taking systemic or topical medications that might confound the outcome or increase the risk of adverse event. Patients taking isotretinoin or amiodarone hydrochloride and any other medication that affects the tear film or accommodation, including but not limited to, mydriatic, cycloplegic and mitotic agents, or any other medications in the investigator's opinion.

4.3.8 Patients with known sensitivity to any planned study medications.

4.3.9 Patients with residual, recurrent, active or uncontrolled eyelid disease.

4.3.10 Patients with significant corneal asymmetry or irregular topography.

4.3.11 Patients with clinically significant anterior segment pathology.

4.3.12 Patients with any corneal abnormality, including but not limited to, slit lamp findings for corneal staining Grade 3 or higher, recurrent corneal erosion or severe basement membrane disease, and pterygium extending onto the cornea.

4.3.13 Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.

4.3.14 Patients with history of Herpes zoster or Herpes simplex keratitis.

4.3.15 Pseudophakic patients that have anterior chamber IOLs, multifocal IOLs, or extended range of vision IOLs in either eye.

4.3.16 Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.

4.3.17 Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP \> 21 mm Hg, or are otherwise suspected of having glaucoma.

4.3.18 Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.

4.3.19 Patients with diabetic retinopathy, collagen, vascular, diagnosed autoimmune disease (e.g., lupus, rheumatoid arthritis, fibromylagia), immunodeficiency (e.g., HIV), connective tissue disease, or clinically significant atopic syndrome.

4.3.20 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing at the opinion of the investigator.

4.3.21 Patients with any type of active cancer (ophthalmic or non-ophthalmic).

4.3.22 Patients with uncontrolled infections of any kind.

4.3.23 Patients who are pregnant, lactating, of child-bearing potential and not practicing a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.

4.3.24 Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.

4.3.25 Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical trials during the time of this clinical investigation.

A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.

What this study is about

A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.

What this study is about