A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects

Presbyopia is a natural outcome of pseudophakic subjects with monofocal or toric intraocular
lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact
lenses, or monovision LASIK, which allows the patient to see near objects. All these options
suffer limitations from the patient perspective. For example, reading glasses can easily be
lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and
instability due to potential rotation and movement of the contact lenses on the surface of
the cornea. And, successful monovision is generally limited to patients with a history of
successful use of contact lenses for monovision, and even in these eyes, monovision is
associated with a substantial decrease in stereo acuity and contrast sensitivity.

ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and
intermediate vision. The inlay is the same refractive index as the human cornea. The inlay is
placed in the non-dominant eye, centered over the pupil after a corneal flap (LASIK) has been
made. The Raindrop Near Vision Inlay is expected to provide low induction of visual symptoms
and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This
technology may also demonstrate potential clinical utility in bilateral pseudophakic
subjects.

Inclusion Criteria:

1. Subjects must provide informed consent, have signed the written informed consent form,
and been given a copy.

2. Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add
from +1.50 D to +2.50 D.

3. Subjects must have uncorrected near visual acuity worse than 20/40 and better than
20/200 in the non-dominant eye.

4. Subjects must have an uncorrected distance visual acuity of 20/25 or better in both
eyes.

5. Subjects must have distance and near visual acuity correctable to at least 20/20 in
both eyes.

6. Subjects must have a manifest refraction spherical equivalent (MRSE) between - 0.50
and +1.00 D with no more than 0.75 D of refractive cylinder in the non- dominant eye.

7. Subjects must have a tear break-up time (TBUT) of ≥8 seconds.

8. Subjects must have a central corneal thickness of between 500 and 600 microns in the
non-dominant eye.

9. Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the
non-dominant eye.

10. Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.

11. Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the
non-dominant eye.

12. Subjects must be willing and able to return for scheduled follow-up examinations for
24 months after surgery.

13. Subjects must have documented monovision tolerance.

14. Subjects must have a minimum of 3 months between cataract surgery and implantation of
the Raindrop Near Vision Inlay in the non-dominant eye.

15. Subjects must be able to demonstrate refractive stability after cataract surgery (e.g.
No change in MRSE greater than ± 0.50 D within the last 2 consecutive visits at least
2 months apart) in the non-dominant eye.

16. Subjects must have a clear or open posterior capsule in the non-dominant eye. -

Exclusion Criteria:

- 1. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or
multifocal intraocular lenses (IOLs) in either eye.

2. Subjects with anterior segment pathology in either eye.

3. Subjects who have worn soft or rigid contact lenses within the past 30 days in the
eye to be treated.

4. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease
(e.g., meibomian gland dysfunction), or any corneal abnormality (including endothelial
dystrophy, guttata, recurrent corneal erosion, etc.) in either eye.

5. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in
either eye.

6. Subjects with distorted or unclear corneal mires on topography maps of the non-
dominant eye.

7. Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.

8. Subjects with macular degeneration, retinal detachment, or any other fundus
pathology that would prevent an acceptable visual outcome in either eye.

9. Subjects who have undergone previous corneal surgery including LASIK surgery in the
non-dominant eye.

10. Subjects with a history of herpes zoster or herpes simplex keratitis.

11. Subjects who have a history of steroid-responsive rise in intraocular pressure,
preoperative IOP > 21 mm Hg, glaucoma, or are a glaucoma suspect in either eye.

12. Subjects with a history of uncontrolled diabetes, autoimmune disease connective
tissue disease, or clinically significant atopic syndrome.

13. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy
that may affect wound healing, and any immunocompromised subjects.

14. Subjects who are using ophthalmic medication(s) other than artificial tears for
treatment of any ocular pathology excluding ocular allergy.

15. Subjects using systemic medications with significant ocular side effects.

16. Subjects with known sensitivity to planned study concomitant medications.

17. Subjects who are participating in any other clinical trial during the course of
this clinical investigation.