Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective
multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with
the PSI and followed for a period of 24 months at up to 14 clinical sites.

An additional randomized sub-study was performed on 48 subjects with the PSI Second
Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to
determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the
observation/deferred implantation control arm. Subjects randomized to the deferred
implantation control arm were eligible to receive the PSI after completion of the 6 months of
observation in the study.

All subjects interested in participating in the study were screened for eligibility, and
informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible
subjects were examined preoperatively to obtain a medical history and baseline ocular data.

Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI
procedure will be included in the study protocol:

- Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and
distance corrected)

- Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and
distance corrected)

The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or
better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an
improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients,
this will translate into the ability to read the majority of newspaper and magazine print
without a near optical aid.

Safety: Primary safety outcomes for safety will include:

- Incidence of anterior segment ischemia

- Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from
baseline at 1-month or more postoperatively

- Decrease in best distance corrected near acuity (with add) of more than 2 lines from
baseline at 1-month or more postoperatively

- Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day
postoperative

- Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2
months or more postoperatively

- Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in
manifest spherical equivalent distance refraction.

- Incidence of adverse events: total not to exceed 5%, and the incidence of each event
should not exceed 1-2%

Inclusion Criteria:

- Subject must be between 50-60 years old

- Subject must have a best corrected distance visual acuity of 20/20 or better

- Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative
eye/eyes of 20/50 to 20/100 (inclusive).

- Subject should have a manifest distance spherical equivalent refractive correction in
the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter
of astigmatism and should require at least a +1.50 diopter add. The distance manifest
refraction spherical equivalent and the distance cycloplegic refraction spherical
equivalent must be within 0.50 diopters of each other.

- Subject must be phakic in the study eye

- Subject must be mentally competent to understand and comply with the requirements of
the study.

- Subject must be able to provide written informed consent.

Exclusion Criteria:

- Chronic uveitis or other recurrent anterior or posterior segment inflammation in
either eye.

- Scleral thickness less than 530 μm in the operative eye/eyes.

- Any previous eye surgeries including cataract, LASIK, or Muscle surgery

- Any history of prior extraocular muscle surgery, specifically the recti or oblique
muscles.

- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.

- Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

- Allergic to any medications used in the study.

- The patient may not have participated in a device clinical study for the operative eye
within the last 3 months and may not have been implanted with PSI devices in this or
any other study.