A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets

Patients must be presbyopic with a reading add from +1.5 to +2.5 D, and both emmetropes (MRSE
from -0.5 to +0.5 D) as well as ametropes (requiring concurrent LASIK) are included in the
investigation. In the non-delayed approach, the corneal pocket is created and inlay implanted
on the same surgical day. In the delayed approach, the corneal pocket is created and
dissected but the corneal inlay is not implanted. After one to three months, the corneal
inlay is implanted on a second surgical day.

1.1 Inclusion Criteria:

1.1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.

1.1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.

1.1.3 Patients have a central corneal thickness ≥ 500 microns in the non-dominant eye.

1.1.4 Patients have corrected distance and near visual acuity of 20/25 or better in each
eye.

1.1.5 Patients have uncorrected near acuity of 20/40 or worse in the non-dominant eye.

1.1.6 Patients are willing and able to understand and sign a written Informed Consent Form
prior to any study-specific procedures.

1.1.7 Patients are willing and able to return for scheduled follow-up examinations for 24
months after corneal inlay implantation.

1.1 Exclusion Criteria:

1.1.1 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.

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

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

1.1.4 Patients who would be co-managed by an ophthalmologist or optometrist who is not
approved as a ReVision Optics investigator.

1.1.5 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.

1.1.6 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, tricyclic,
phenothiazines, benzodiazepines, and first generation antihistamines.

1.1.7 Patients with known sensitivity to any planned study medications. 1.1.8 Patients with
residual, recurrent, active or uncontrolled eyelid disease. 1.1.9 Patients with significant
corneal asymmetry or irregular topography. 1.1.10 Patients with clinically significant
anterior segment pathology. 1.1.11 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.

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

1.1.13 Patients with history of Herpes zoster or Herpes simplex keratitis. 1.1.14 Patients
with any progressive retinal disease or patients with a history or evidence of retinal
vascular occlusion and/or hypercoagulability, because of the risks associated with high
pressures during suction application.

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

1.1.16 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.

1.1.17 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 such as allergies or asthma.

1.1.18 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that
may affect wound healing.

1.1.19 Patients with any type of active cancer (ophthalmic or non-ophthalmic). 1.1.20
Patients with uncontrolled infections of any kind. 1.1.21 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.

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

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