El documento describe un dispositivo implantable llamado KAMRA que mejora la visión cercana en pacientes presbíticos. Se ha implantado en más de 20,000 pacientes y está aprobado en 49 países. Proporciona una profundidad de enfoque aumentada sin afectar negativamente otras pruebas oculares o procedimientos. Los resultados son estables a largo plazo, mejorando la visión cercana y intermedia con mínimos cambios en la visión lejana.
2. ACUFOCUS
Mas de 20,000 dispositivos implantados
mundial
Aprobado comercialmente en 49 países:
• Europa
• Asia-Pacifica
• Medio Oriente
• Norte y Sud América
3. Características deseables:
Delgado, diámetro pequeño
Permeabilidad alta
Colocado profundo en la
estroma
Objetivo:
Mínimo disrupción del flujo
molecular e evitar cambios de
curvatura de la superficie
KERATOFISCOLOGÍA Y KAMRA
Photo Courtesy of Stephen Klyce, PhD
An intralamellar water impermeable membrane is a barrier to
gradient flow of water and nutrients across the cornea. The water
gradient is created by evaporation from the tear film. The nutrient
gradient is created by the tissue metabolism.
4. DISEÑO DEL DISPOSITIVO KAMRA™
1.6mm
Aperture
5 μm
Grosor
Hecho de Polyvinylidene Fluoride (PVDF)
8,400 Micra-
perforaciones
(5-11 μm)
3.8mm
Diámetro
Deseno del Dispositivo
Inlay in vivo
Image courtesy of Dr. Minoru Tomita
Shinagawa LASIK Center
• La visión mejora por que la abertura pequeña aumenta el fondo de
enfoque
• La abertura central es un agujero sin aumento
• La abertura pequeña permite que los rayos de luz entre el ojo
5. CASI INVISIBLE
Socialmente no se nota el dispositivo, ni
en ojos claros
Se puede nota:
Bajo condiciones de luz brillante y mirando:
De cerca y/o de costado
De frente si la pupila del otro ojo es mas pequeño de 3.8mm
6. BIOCOMPATIBILIDAD DEL MATERIAL
Fabricado del material Polyvinyledene
Fluoride (PVDF) y nano-particulas de
carbón
• Utilizados en los apticos de LIO por mas de
20 años
• Verificado con estudios de ISO 11979 y
10993 (estudios en corneas de conejos)*
• Las corneas se mantiene claras y no
reaccionan con el material del dispositivo*
* Data on file at AcuFocus
7. PROFUNDIDAD DE ENFOQUE SIN KAMRA
OQAS Depth of Focus (D): 0.25
Optical Quality Analysis System - Visiometrics (Spain)
Fondo de enfoque y calidad de imagen de un présbita
de 49 años sin KAMRA
Análisis con
OQAS
muestra el
ojo sin
KAMRA tiene
un fondo de
enfoque
0.25D
8. PROFUNDIDAD DE ENFOQUE CON KAMRA
Optical Quality Analysis System - Visiometrics (Spain)
Fondo de enfoque y calidad de imagen de un présbita
de 49 años con KAMRA
Análisis con
OQAS muestra
el ojo con
KAMRA tiene
un fondo de
enfoque
>2.50D
9. PROFUNDIDAD DE ENFOQUE SIMULADO
Con KAMRA:
Cámara fotográfica SLR simula
visión de una pupila de
tamaño 1.6 mm
Enfoque @ 7.69 pies, f-stop 22
Sin KAMRA:
Cámara fotográfica SLR
simula visión de una pupila
de tamaño 4.00 mm
Enfoque @ 7.69 pies, f-stop
5.6
Sin KAMRA:
Cámara fotográfica SLR
simula visión de una pupila
de tamaño 4.00 mm
Enfoque @ 7.69 pies, f-stop
5.6
10. Células Endotelio Keratocytes
Nervios Corneales
BIEN TOLERADO EN LA CORNEA
Imagen de cornea con el dispositivo implantado usando el
microscopio confocal
11. OCT
• La cornea se ve calma pos-op
• Grosor del flap esta uniforme
BIEN TOLERADO EN LA CORNEA
12. NUTRICIÓN CORNEAL
• El metabolismo del epitelio corneal
muestra ser mas activo que todas las
otras células corneales
• El requerimiento nutricional viene del
humor acuoso
• Es importante mantener el flujo de
glucosa y otro metabolitos para la salud
del epitelio corneal AqueousAqueous
Tear FilmTear FilmTear FilmTear Film
14. NUTRICIÓN CORNEAL
Los agujeros difusos cubren aproximadamente 5% del área
del insumo
El patrón de los orificios del dispositivo mantiene el flujo
de metabolitos para la salud del epitelio corneal
15. Procedimientos Quirúrgicos
Pocket Emmetropic
KAMRA
(PEK)
200-250μm
Pocket
Descripción:
Se coloca el dispositivo en el
bolsillo formado a una
profundidad de . 200-250μm
Paciente ideal:
Présbitas Emétropes
pseudofaquico
Endothelium
Epithelium
BOLSILLOBOLSILLO
Post-LASIK KAMRA (PLK)
and Planned LASIK
KAMRA – 2 Step
(PLK2)
Descripción:
El flap normal de LASIK se corta
a 100μm. Un mes después se
crea un bolsillo 100μm bajo el
flap original, y se coloca el
dispositivo dentro del bolsillo.
Paciente ideal:
Présbitas Amétropes
Pos-LASIK présbitas
Pocket
100μm
LASIK Flap
Should be at least 150μm
Epithelium
100μm
Endothelium
DUAL-INTERFACEDUAL-INTERFACE
16. PROCEDIMIENTO: BOLSILLO:
AGUDEZA VISUAL CERCANA Y LEJANA
En general pacientes obtienen 20/28
UCNVA y 20/20 UCDVA.
N=8905 N=8675 N=8155 N=7180 N=6044 N=3899 N=1849 N=749
Decimal
Exam
20/25, J2
*Data on file at AcuFocus
17. STEREOACUITY PEK PATIENTS
• There is no change in
mean distance
stereoacuity scores
between pre-op and 6
months post-inlay
implantation*
* Dr. Linn, Hoopes Vision Institute, ARVO 2012.
N=60
18. 0
0.5
1
1.5
2
2.5
0 3 6 9 12 15 18 21
ContrastSensivity Frequency(c/ deg)
PreOp
12M
24M
Low Normal
High Normal
• There is a small reduction in photopic and mesopic contrast sensitivity however
scores remains within normal limits at 24 months post-op.
• Ultimately the reduction is minor when compared to the benefits of the inlay**
Binocular Contrast Sensitivity - Mesopic Binocular Contrast Sensitivity - Photopic
**Seyeddain et al. Small-aperture corneal inlay for the correction of
presbyopia: 3-year follow-up. J Cataract Refract Surg 2012; 38:35-45
0
0.5
1
1.5
2
2.5
3
0 3 6 9 12 15
ContrastSensivity
Frequency(c/deg)
PreOp
12M
24M
Low
Normal
High
Normal
Pre N = 508
12 M N = 479
24M N = 442
Binocular Contrast Sensitivity - Mesopic
*Data on file at AcuFocus
*
*
Pre N = 508
12 M N = 479
24M N = 442
*Data on file at AcuFocus
*
*
Binocular Contrast Sensitivity
PEK Patients
19. 1
2
3
4
5
6
7
Reading newspaper
day
Reading book day
Viewing computer
day
Seeing numbers on
PDA day
Seeing small print
day
Performing small
item tasks day
Reading newspaper
dim
Reading book dim
Viewing computer
dim
Seeing numbers on
PDA dim
Seeing small print
dim
Performing small
item tasks dim
Near Vision Task Ra ngs at 24 months (All
Eyes)
Pre-op
24 Mon
“How easy is it to
perform a series of
near vision tasks with
both eyes without
their glasses?”
1 = Not easy at all
7 = Very easy
• At 24 months post-op, statistically significant improvement is
seen in mean scores for performing near tasks in both dim &
bright light conditions (p=0.00)
NEAR VISION TASK RATINGS
PEK PATIENTS
20. “How easy is it to
perform a series of
near vision tasks with
both eyes without
their glasses?”
1 = Not easy at all
7 = Very easy
• Reported ease of distance task performance remained stable at
24 months post-op, with little to no change in ranking (p=0.016)
DISTANCE VISION TASK RATINGS
PEK PATIENTS
21. SYMPTOMS RATINGS
• Patients reported low incidence of visual symptoms 24
months post-operatively including glare, halo and night
vision problems
“Please indicate which, if
any, of these conditions
you have experienced in
the past 4 weeks.”
0 = Have not experienced
1= Very mild
7 = Very severe
22. LONG-TERM RESULTS:
UNCORRECTED NEAR VA AT 5 YEARS
Data courtesy of Günther Grabner, MD
• UCNVA improved from a mean of J8 to J2 in the inlay eye (IE) between
preop and 1 month. This result is maintained out to 5 years.
• Vision in the inlay eye and with both eyes (BE) is unaffected by the
progression of presbyopia.
• UCNVA in the untreated other eye (OE) shows an mean loss of 1 line over
the same time period.
0
10
20
30
40
50
60
0 10 20 30 40 50 60
ETDRSletters
Month
UCNVA
IE
OU
Mean
Loss*
23. VIRTUALLY UNDETECTABLE
In social circumstances the inlay is
virtually undetectable – even in light
colored eyes
The inlay is only visible:
Bright light conditions either from:
An oblique angle up close, or
Straight on if the fellow eye pupil is smaller than 3.8mm
24. REMOVABLE
Additive procedure
Doesn’t restrict future options
Yilmaz et al. reported all patients in their series
requiring inlay removal*
:
• Returned to within +/- 1.00D of their preoperative
refraction after inlay removal
• No loss of corrected acuity
*J Cataract Refract Surge 2011; 37:1275-1281
25. VENTAJA DE HACER EL BOLSILLO
Significativamente mejora la estabilidad y resultados
refractivos
Reduce la incidencia de resequedad ocular
Mejora la satisfacción del paciente
Simplifica la posición del dispositivo
Mejora la facilidad de recuperar la visión
26. TOPOGRAFÍA PRE- Y POS-OP
Esencialmente no ocurren cambios en la topografía
Pre-op 3 month
29. CHAMBER ANGLE IMAGE
Chamber angle
imaging can be
achieved with the
inlay in place
Image courtesy of Günther Grabner, MD
30. Cataratas y opacidades pueden ser fácilmente detectadas con pupila
dilatada
LENTE CRISTALINO
31. PERIFERIA
El dispositivo no afecta la
habilidad de tomar fotos o
evaluar la retina
Image courtesy of Günther Grabner, MD
32. IMAGEN DEL NERVIO ÓPTICO
6 MESES POS-OP
Nervio Óptico y RNFL
fácilmente obtenible .
33. CAMPO VISUAL
Campo visual permanece dentro los limites normales
Datos de los estudios clínicos demuestran una reducción mínima en la sensibilidad (~1.0 dB
cambio del ‘baseline’).1
No produce escotomas 1,2
No hay un cambio significante comparando el campo completo entre ojos con y sin el dispositivo3
Pre-Op: Inlay Eye 36 Mo Post-Op: Inlay Eye
1 - US IDE Clinical Trial
2 – Sanchez et al, ARVO 2012
3 – Brooker et al, ARVO 2013
34. RESUMEN
• Hasta la fecha hay mas de 20,000 dispositivos
implantados
• Mejora agudeza cercana y intermedia
• Mínimo cambios en la vista lejana
• Resultados son estable en largo plazo
• No afecta otro exámenes o procedimientos
quirúrgicos
SC-018 Rev A
Notas del editor
Nearly 20,000 inlays have been implanted in commercial accounts and clinical trial sites
The inlay is available in 49 countries, with recent approvals in Korea, Canada, Argentina, and Mexico
The inlay is an opaque, annular device with a diameter of 3.8 mm and a central hole or aperture measuring 1.6 mm
The inlay works based on the depth of focus principle or pinhole
It only allows focused light to reach the retina and restricts the light that would otherwise blur the patients vision
It is made of polyvinylidene flouride, a highly biocompatible material used in IOL haptics
In everyday circumstances, the inlay is unnoticeable even in light colored eyes
Replace image
New inlay image
Paired Student t-test, p=0.00
Paired Student t-test= 0.016
5 year data demonstrates long term safety and efficacy of the inlay
Improvement in UCNVA in the inlay eye is maintained
Though the fellow eye loses an average of 1 line UCNVA, binocular vision remains unaffected by progression of presbyopia
In everyday circumstances, the inlay is unnoticeable even in light colored eyes
Yimaz Removals Detail:
4 inlays in total removed over the 4 year follow-up out of a total of 39 patients
Mean age for these patients was 52
1 was removed at 6 weeks due to a buttonhole detected at the slitlamp (one month post removal acuity was UNVA - 20/40 and UDVA - 20/20 with SE +0.25D, two years post-removal acuities were the same and SE was +1.00D)
2 inlays were removed at 3 months due to refractive shifts (one myopic -2.00 and one hyperopic +3.00D) – both returned to within +1.00D of preop (both preop SE +0.25D) with no loss of CDVA
1 inlay removed 17 months post due to patient complaints (myopic shift) and identification of the flap being too thin (intraop pachymetry not available at the time of surgery so the thin flap was missed). Eye returned to preop refractive state with no loss of CDVA, CNVA or UNVA