| Eligibility |
Inclusion Criteria:
4.2.1 Presbyopic patients 41-65 years of age.
4.2.2 Pseudophakic patients at least 50 years of age.
4.2.3 Patients require a near reading add from +1.50 to +2.50 D in the non-dominant eye.
4.2.4 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
4.2.5 Patients have a corneal thickness greater than or equal to 500 microns in the
non-dominant eye.
4.2.6 Patients have corrected distance and near visual acuity of 20/25 or better in each
eye.
4.2.7 Patients have distance corrected near visual acuity of 20/40 or worse in each eye.
4.2.8 Patients have no more than a 0.75 D difference at preop between MRSE and cycloplegic
refraction spherical equivalent determined at the spectacle plane of each eye.
4.2.9 Patients have targeted MRSE from -0.5 to +1.0 D in the non-dominant eye, with no more
than 0.75 D of manifest cylinder with or without LASIK.
4.2.10 Patients are willing and able to sign a written Informed Consent Form prior to any
study-specific procedures.
4.2.11 Pseudophakic patients must be at least 3 months after cataract surgery.
4.2.12 Pseudophakic patients must have clear posterior capsule, open posterior capsule
(post YAG Capsulotomy), or posterior capsule opacification that is not clinically
significant at the opinion of the investigator.
4.2.13 Patients are willing and able to return for scheduled follow-up examinations for 24
months after the corneal inlay surgery.
Exclusion Criteria
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.
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