Clinical and Experimental Ophthalmology,
Journal Year:
2025,
Volume and Issue:
unknown
Published: Jan. 31, 2025
ABSTRACT
Background
To
assess
the
safety
and
stability
profile
of
suprachoroidal
retinal
prosthesis
(ScRP)
in
participants
with
retinitis
pigmentosa
(RP)
for
2
years
from
implantation.
Methods
Four
participants,
advanced
RP
bare‐light
perception
vision
were
enrolled
a
prospective,
single
arm
unmasked
interventional
clinical
trial
unilaterally
implanted
44‐channel
ScRP
(NCT03406416).
Electrical
stimulation
commenced
psychophysics
laboratory
prior
to
use
local
environments.
Outcome
measures
included
serious
adverse
events,
implant
functionality
over
2.0–2.7
years.
Results
Surgical
procedures
took
204–260
min
uncomplicated.
Postoperative
recovery
was
uneventful.
Imaging
confirmed
device
position
under
macula
absence
trauma.
There
no
events
that
occurred
mild.
All
electrodes
functional
at
surgery
completion,
only
3%
lost
by
study
end.
minor
array
movement
(translational
rotational)
within
first
10–15
weeks
only.
The
electrode
retina
distance
increased
as
expected
fibrous
capsule
development,
but
plateaued
three
four
12
months.
Retinal
choroidal
thicknesses
consistent
underlying
dystrophic
disease.
Conclusions
can
be
safely
space
has
minimal
long‐term
impacts
on
eye,
SAEs
slight
seen
Hence,
findings
indicate
approach
feasibility
further
multicentre
studies
are
warranted.
Ophthalmology,
Journal Year:
2020,
Volume and Issue:
127(8), P. 1097 - 1104
Published: Feb. 25, 2020
Loss
of
photoreceptors
in
atrophic
age-related
macular
degeneration
results
severe
visual
impairment,
although
some
peripheral
vision
is
retained.
To
restore
central
without
compromising
the
residual
field,
we
developed
a
wireless
photovoltaic
retinal
implant
(PRIMA;
Pixium
Vision,
Paris,
France)
which
pixels
convert
images
projected
from
video
glasses
using
near-infrared
light
into
electric
current
to
stimulate
nearby
inner
neurons.We
carried
out
first-in-human
clinical
trial
test
safety
and
efficacy
prosthesis
patients
with
geographic
atrophy
(ClinicalTrials.gov
identifier,
NCT03333954).Five
zone
at
least
3
optic
disc
diameters,
no
foveal
perception,
best-corrected
acuity
20/400
20/1000
worse-seeing
study
eye.The
2-mm
wide,
30-μm
thick
chip,
containing
378
(each
100
μm
diameter),
was
implanted
subretinally
area
(absolute
scotoma).Anatomic
outcomes
were
assessed
fundus
photography
OCT
for
up
12
months
follow-up.
Prosthetic
by
mapping
bar
orientation,
letter
recognition,
Landolt
C
acuity.In
all
patients,
successfully
under
macula,
2
it
unintended
locations:
within
choroid
off
center
mm.
All
5
could
perceive
white-yellow
prosthetic
patterns
adjustable
brightness
previous
scotomata.
The
optimal
placement
demonstrated
20/460
20/550,
patient
off-center
20/800
acuity.
Residual
natural
did
not
decrease
after
implantation
any
patient.Implantation
PRIMA
acuity,
restored
sensitivity
former
scotoma
each
patients.
In
proper
only
10%
30%
less
than
level
expected
pixel
pitch
(20/420).
Therefore,
use
optical
or
electronic
magnification
as
well
smaller
future
implants
may
improve
even
further.
Progress in Retinal and Eye Research,
Journal Year:
2018,
Volume and Issue:
69, P. 38 - 56
Published: Nov. 9, 2018
Cell
replacement
therapy
is
a
promising
treatment
for
irreversible
retinal
cell
death
in
diverse
diseases,
such
as
age-related
macular
degeneration
(AMD),
Stargardt's
disease,
retinitis
pigmentosa
(RP)
and
glaucoma.
These
diseases
are
all
characterized
by
the
of
one
or
two
types
that
cannot
regenerate
spontaneously
humans.
Aberrant
pigment
epithelial
(RPE)
cells
can
be
observed
through
optical
coherence
tomography
(OCT)
AMD
patients.
In
RP
patients,
morphological
functional
abnormalities
RPE
photoreceptor
layers
caused
genetic
abnormality.
disease
juvenile
degeneration,
which
loss
photoreceptors
area,
causes
central
vision
at
an
early
age.
Loss
ganglion
(RGCs)
patients
with
Once
triggered,
no
treatments
reverse
it.
Transplantation-based
approaches
have
been
proposed
universal
to
target
various
concomitant
diseases.
Both
dead
neuroprotection
strategies
used
rescue
visual
function
animal
models
degeneration.
Diverse
derived
from
pluripotent
stem
cells,
including
photoreceptors,
RGCs
even
organoids
layered
structure,
provide
unlimited
sources
transplantation.
addition,
mesenchymal
(MSCs)
multifunctional
protect
degenerating
cells.
The
aim
this
review
summarize
current
findings
preclinical
clinical
studies.
We
begin
brief
introduction
degenerative
followed
methods
generation.
Preclinical
studies
discussed,
future
concerns
about
efficacy,
safety
immunorejection
also
addressed.
Therapeutic Advances in Ophthalmology,
Journal Year:
2019,
Volume and Issue:
11
Published: Jan. 1, 2019
Retinal
prosthesis
systems
have
undergone
significant
advances
in
the
past
quarter
century,
resulting
development
of
several
different
novel
surgical
and
engineering
approaches.
Encouraging
results
demonstrated
partial
visual
restoration,
with
improvement
both
coarse
objective
function
performance
everyday
tasks.
To
date,
four
received
marketing
approval
for
use
Europe
or
United
States,
numerous
others
undergoing
preclinical
clinical
evaluation,
reflecting
established
safety
profile
these
devices
chronic
implantation.
This
progress
represents
first
notion
that
field
restorative
medicine
could
offer
blind
patients
a
hope
real
measurable
benefit.
However,
there
are
complex
biophysical
obstacles
still
to
be
overcome,
reconcile
gap
remains
between
artificial
natural
vision.
Current
developments
form
enhanced
image
processing
algorithms
data
transfer
approaches,
combined
emerging
nanofabrication
conductive
polymerization
techniques,
herald
an
exciting
innovative
future
retinal
prosthetics.
review
provides
update
prosthetic
currently
trials
while
also
addressing
challenges
field,
such
as
assessment
functional
outcomes
ultra-low
vision
strategies
tackling
existing
hardware
software
constraints.
Nature Communications,
Journal Year:
2018,
Volume and Issue:
9(1)
Published: March 2, 2018
Abstract
Retinal
prostheses
have
been
developed
to
fight
blindness
in
people
affected
by
outer
retinal
layer
dystrophies.
To
date,
few
hundred
patients
received
a
implant.
Inspired
intraocular
lenses,
we
designed
foldable
and
photovoltaic
wide-field
epiretinal
prosthesis
(named
POLYRETINA)
capable
of
stimulating
wireless
ganglion
cells.
Here
show
that
within
visual
angle
46.3
degrees,
POLYRETINA
embeds
2215
pixels,
which
967
are
the
central
area
5
mm,
it
is
allow
implantation
through
small
scleral
incision,
has
hemispherical
shape
match
curvature
eye.
We
demonstrate
not
cytotoxic
respects
optical
thermal
safety
standards;
accelerated
ageing
shows
lifetime
at
least
2
years.
represents
significant
progress
towards
improvement
both
acuity
field
with
same
device,
current
challenging
issue
field.
Nature Communications,
Journal Year:
2022,
Volume and Issue:
13(1)
Published: July 4, 2022
Abstract
Electronic
visual
prostheses,
or
biomimetic
eyes,
have
shown
the
feasibility
of
restoring
functional
vision
in
blind
through
electrical
pulses
to
initiate
neural
responses
artificially.
However,
existing
prostheses
predominantly
use
wired
connections
electromagnetic
waves
for
powering
and
data
telemetry,
which
raises
safety
concerns
couples
inefficiently
miniaturized
implant
units.
Here,
we
present
a
flexible
ultrasound-induced
retinal
stimulating
piezo-array
that
can
offer
an
alternative
wireless
artificial
prosthesis
approach
evoking
percepts
individuals.
The
device
integrates
two-dimensional
with
32-pixel
electrodes
printed
circuit
board.
Each
piezo-element
be
ultrasonically
individually
activated,
thus,
spatially
reconfigurable
electronic
patterns
dynamically
applied
via
programmable
ultrasound
beamlines.
As
proof
concept,
demonstrate
pattern
reconstruction
ex
vivo
murine
tissue,
showing
potential
this
restore
functional,
life-enhancing
people
living
blindness.
Chemical Society Reviews,
Journal Year:
2024,
Volume and Issue:
53(17), P. 8632 - 8712
Published: Jan. 1, 2024
Bioelectronics
is
a
hot
research
topic,
yet
an
important
tool,
as
it
facilitates
the
creation
of
advanced
medical
devices
that
interact
with
biological
systems
to
effectively
diagnose,
monitor
and
treat
broad
spectrum
health
conditions.
Electrical
stimulation
(ES)
pivotal
technique
in
bioelectronics,
offering
precise,
non-pharmacological
means
modulate
control
processes
across
molecular,
cellular,
tissue,
organ
levels.
This
method
holds
potential
restore
or
enhance
physiological
functions
compromised
by
diseases
injuries
integrating
sophisticated
electrical
signals,
device
interfaces,
designs
tailored
specific
mechanisms.
review
explains
mechanisms
which
ES
influences
cellular
behaviors,
introduces
essential
principles,
discusses
performance
requirements
for
optimal
systems,
highlights
representative
applications.
From
this
review,
we
can
realize
based
bioelectronics
therapy,
regenerative
medicine
rehabilitation
engineering
technologies,
ranging
from
tissue
neurological
modulation
cardiovascular
cognitive
functions.
underscores
versatility
various
biomedical
contexts
emphasizes
need
adapt
complex
clinical
landscapes
addresses.
Progress in Retinal and Eye Research,
Journal Year:
2018,
Volume and Issue:
69, P. 1 - 37
Published: Nov. 13, 2018
The
mammalian
retina
displays
no
intrinsic
regenerative
capacities,
therefore
retinal
degenerative
diseases
such
as
age-related
macular
degeneration
(AMD)
or
retinitis
pigmentosa
(RP)
result
in
a
permanent
loss
of
the
light-sensing
photoreceptor
cells.
photoreceptors
leads
to
vision
impairment
and,
later
stages,
complete
blindness.
Several
therapeutic
strategies
have
been
developed
slow
down
prevent
further
degeneration,
however
definitive
cure
i.e.
replacement
lost
photoreceptors,
has
not
yet
established.
Cell-based
treatment
approaches,
by
means
transplantation,
studied
pre-clinical
animal
models
over
last
three
decades.
introduction
pluripotent
stem
cell-derived
organoids
represents,
principle,
an
unlimited
source
for
generation
transplantable
human
photoreceptors.
However,
safety,
immunological
and
reproducibility-related
issues
regarding
use
cells
still
need
be
solved.
Moreover,
recent
finding
cytoplasmic
material
transfer
between
donor
host
demands
reinterpretation
several
former
transplantation
studies.
At
same
time,
healthy
dysfunctional
patient
also
offers
potential
alternative
strategy
intervention.
In
this
review
we
discuss
history
current
state
techniques
used
assess
rescue
visual
function,
prerequisites
effective
well
main
roadblocks,
including
safety
immune
response
graft,
that
overcome
successful
clinical
translation
approaches.