Prospective multicenter clinical trial with the PRECIZION Presbyopic multifocal intraocular lens

Accommodation is the ability of the eye to dynamically change its optical power
to create a sharp image of distant, intermediate, and near objects on the
retina. Helmholtz et al. suggested that accommodation is the result of changes
in the optical power of the crystalline lens as a result of changes in the lens
shape and position due to changes in tension exerted on the zonular fibers
after relaxation or contraction of the ciliary muscle. As people age, the
ability to accommodate decreases, resulting in presbyopia. This thought to be
the result of changes in the elasticity of the crystalline lens and in the
contractility of the ciliary muscle.

Advances in cataract surgery and intraocular lens (IOL) design have resulted in
the ability to correct presbyopia by means of multifocal IOLs. These IOLs aim
to restore vision at more than one specfic distance. Multifocal IOLs come in
different designs. The most common designs are diffractive versus refractive.
Refraction is based on a change in direction of the light ray due to a change
in the optical density of the material transmitting the light ray. Diffraction
is based on the observation that light that encounters a discontinuity or edge
in the material in which it travels scatters in numerous directions. Light
energy arriving at an edge or discontinuity can thus be divided over 2 or more
focal points, similar to refractive IOLs.

Refractive multifocal IOLs designs traditionally have 2 segments, one for far
vision and one for near vision. Centration of the IOL in the capsular bag is of
great importance, because decentration may lead to an altered ratio between far
and near vision correction. This directly affects the uncorrected visus for
near and far vision. In addition, the pupil size of the patient also affects
the ratio near/far correction.
To solve these problems with refractive multifocal IOLs, OPHTEC BV., has
developed a segmented multifocal IOL that is pupil size / decentration
independent. The IOL has 11 segments, 5 for far vision and 6 for near vision.
The segments are distributed in such a way, that decentration of pupil size has
a minimal effect on the ratio between near and far correction.

The IOL is initially tested with the VirtIOL device (101Lens S.L.U.). The
device projects the IOL in the pupil of the patients eye and this allows
simulation of the vision trough the IOL before surgery. The tests showed good
visual acuity performance for far, intermediate and near vision. During the
throughfocus scanning, the IOL had nearly constant visual acuity (VA) values.
VA*s were unaffected by orientation of the IOL.

The main objective of this study is to evaluate the ability of the PRECIZION
Presbyopia IOL to provide near, intermediate and distance vision in patients
undergoing cataract extraction and intraocular lens implantation. Study
outcomes will be used to obtain CE marking for the lens and for registration
and marketing purposes.

The study is a prospective, open-label, single-arm, multicenter clinical
evaluation. Sixty consecutive patients will be enrolled at 6 investigational
sites, undergo bilateral cataract extraction with PRECIZION Presbyopia IOL
implantation and followed for a period of 3 months. Bilateral implantation is
necessary to obtain satisfying visual results. Each investigator should enroll
between 6-15 subjects. Enrollment will stop once the target enrollment number
is achieved.

A phased enrollment is implemented in order to optimize IOL calculation
constants and to monitor visual acuity results. IOL constants of the PRECIZION
Presbyopia IOL are based on the PRECIZION monofocal IOL but may need to be
adjusted. Phase II will start once 3 month follow-up data has been obtained
from phase I group.

Subject will receive the PRECIZION Presbyopia multifocal IOL in both eyes
(bilateral implantation). Surgical procedure and medication regime are standard
for cataract surgery.

The anticipated clinical benefit of the PRECIZION Presbyopic is improved
uncorrected near, intermediate visual acuities and distance visual acuity for
presbyopic patients, resulting in reduced need for the use of glasses for near
or intermediate vision tasks (reading glasses or computer glasses) and in best
case resulting in complete spectacle independency.

The risk analysis showed that implantation of the PRECIZION Presbyopic IOL
includes the same risks for the patient as regular surgery with the PRECIZION
Monofocal or Toric lenses. There are additional risks associated with the
multifocal optic. There is a risk that the patient experiences dysphotopsia
(glare, halos, starburst, diplopia, loss of contrast sensitivity) that may
disturb vision or hinder the patient in normal functioning and that may lead to
patient dissatisfaction. In the worst case, secondary surgical re-intervention
may be required to exchange the lens for a different model. Secondary surgical
re-intervention results in a repeated exposure of the patient to general
surgery-related risks, but in principle this worst case scenario demonstrates
the reversibility of the procedure and prevents permanent harm to the patient.
Risks were reduced to broadly acceptable risk (BAR) or as low as reasonably
possible (ALARP) level. Product safety and performance are in accordance with
specifications. Product safety and performance are in accordance with
specifications. Product design is in accordance with its intended use.

Most complications can be avoided by careful patient selection according to the
IFU. The severity of complications can be limited by early detection and
treatment. Compliance with the postoperative monitoring recommendations is
therefore crucial. If patient selection is performed in accordance with the
protocol the benefits to the patient outweigh the risks.