Download Corneal Inlays - The New Frontier

Slide 1
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VA N D I R I M E R , O D
D I PLOM AT, A M E RI CA N B OA RD OF OPTOM E TRY
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[email protected]
3 0 3 - 74 0 - 5 4 7 5
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Slide 2
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PRESBYOPIA
Ahhhh, the presbyope!
“I want to see all
distances without
glasses”
As clinicians we have all
heard this, probably at
least once a day.
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What are your options?
 Bifocals
 Progressives
 Mono vision contacts
 Multi-focal contacts
 Multi-focal IOL’s
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Slide 3
PRESBYOPIA
The newest option
in our near
future…………
CORNEAL
INLAYS
3 Inlay Designs
• Kamra
• Raindrop
• Presvia Flexivue
Microlens
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Slide 4
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CORNEAL INLAYS
•
3 variations on the concept of placing an implant inside the
cornea are in different stages of the approval process.
•
Kamra inlay (from AcuFocus in Irvine, Calif.) Uses the pinhole
principle to increase depth of field
•
Raindrop (from ReVision Optics in Laguna Hills, Calif.) makes the
cornea multifocal by reshaping it
•
Flexivue Microlens (from Presbia in Amsterdam) creates
multifocal vision using an in-cornea lens.
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Slide 5
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KAMRA INLAY
•
•
•
•
Inlay is placed under a
corneal flap
It can be placed in an
emmatropic eye or after
LASIK procedure has
been performed
The inlay is placed into
the non dominant eye
The Kamra inlay is
commercially available
in 49 countries, and
nearly 20,000 inlays
have been implanted
worldwide to date
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Slide 6
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3.8mm
Total diameter
1.6mm
Aperture
5μ
Thick
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Slide 7
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8,400
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micro-perforations
(5-11µ)
Pseudo-random
pattern
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Maximize
nutrient flow
Minimize visual
symptoms
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Slide 8
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KAMRA INLAY
 The KAMRA™ (Acufocus, Inc.)
 Inlay extends uses small aperture optics to depth of focus
 Published clinical and commercial results are similar:
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 Mean UNVA: J1 with 96-97% of eyes J3 or better
 Mean UIVA: 20/20 - 20/25
 Mean UDVA: 20/20
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 Can be used to treat a broad range of presbyopes
 Result remains stable over the long-term
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Slide 9
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Slide 10
Reading Performance after Small-Aperture Corneal Inlay
Journal of Cataract and Refractive Surgery March 2011
•
Improved near visual acuity in all 32 patients
•
Mean improvement of 2.7 +/- 1.6 lines of near vision
•
LogMAR of 0.38 +/-0.14 (approx 20/50)
•
Improved vision due to increased depth of field based on
small aperture optics.
•
Completely reversible procedure
•
Distance acuity was maintained at 20/20
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Slide 11
KAMRA INLAY RESULTS
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MEDSCAPE.COM -FDA PANEL DELIVERS MIXED VERDICT ON KAMRA CORNEAL INLAY JUNE 9, 2014
The primary effectiveness endpoint,
• 75% of the subjects achieving uncorrected near visual
acuity of 20/40 or better at 12 months,
• 83.5% of the 478 subjects who completed 12 months
of the study and remaining consistent through 36
months.
• Participants had a mean 2.9-line gain at month 12.
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Slide 12
KAMRA INLAY RESULTS
•
Subject satisfaction questionnaires on a scale of 1- 7
• Baseline near vision was 1.7 and improved to 4.7 at 12 months
• Remained consistent at 4.7 for 3 years
•
Safety findings by clinical investigator Jay S Pepose, MD, Phd
• 0.6% rate of persistent BCDV LOSS of 2 lines or more at consecutive visits at 12
months
• 0% incidence of BDCVA worse than 20/40 if they were 20/20 or better pre op
• 3.3% of patients had increased ocular pressure
• 5.9% with decreased BCDVA more than 2 lines at 3+ months
• Outcomes were better in procedures with a femtosecond laser that created a
“POCKET” rather than a flap.
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Slide 13
KAMRA INLAY – INTRALASE POCKET
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In a subsequent confirmatory trial of 151 subjects
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Using an intralase pocket with a separation of spot/line settings of 6x6 microns
as the surgical standard.
•
Primary endpoint improved to 90.8% with a drop in inlay removals caused by
refractive changes. Outcomes went from 6.9% to 2.7%. The 6x6 is now the
standard.
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Slide 14
KAMRA
• Being able to remove the inlay if the patient is
unhappy is a big advantage. “Previous papers
have reported that patients’ refractive state
returned to within ±1 D of the preoperative
refractive state after inlay removal, with no
loss of corrected distance visual acuity.
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Slide 15
FDA – MIXED VERDICT
• Panel members were convinced 7 to 1 that there is
"reasonable assurance" it improves near vision in
presbyopic patients
• However, the committee split down the middle 4 to 4,
on the question of reasonable assurance of safety
• triggering a tie-breaking "no" vote from committee
chair Neil M. Bressler, MD. on a third question,
whether the inlay's benefits outweigh its risks, the
vote was 4 yes, 3 no, and 1 abstention.
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Slide 16
FDA’S TAKE
•
FDA Chief Ophthalmic medical officer Eva Rorer, MD faulted AcuFocus for
excluding 8.7 (44) subjects for removing the lens because of visual problems,
they believe the subjects should have been counted as failures- which dropped
the endpoint to 75.8%
•
Only 25% from both trials gained 4 or more lines of UCNVA, which is equal to 1D
of accommodation.
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One of the “no” votes from Dr. Alvin Eisner, PhD was due to concerns about
outcome of explanted patients over time and the uncertainty of hyperopic shift
over time. In addition, the intereference of the device with ophthalmic
examinations. The device may affect the clinicians ability to see the retina.
•
The “abstain” vote by Dr. Dahr stated it is very difficult to determine “Benefit”
when there is such a subjective variability from patient to patient when it comes
to a patient’s “perceived” benefit.
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Slide 17
PRESVIA FLEXIVUE MICROLENS
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Slide 18
FLEXIVUE MICROLENS INLAY
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Slide 19
FLEXIVUE MICROLENS
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• Placed into a stromal
pocket instead of
under flap
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• Ziemer Femto laser
device with a
proprietary pocketmaking algorithm
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• Pre-loaded delivery
system
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Slide 20
THE PRESBIA FLEXIVUE MICROLENS
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• Small, hydrophilic acrylic refractive inlay
• 3.2 mm wide, with a 1.6-mm hole in the center.
• The refractive power of the ring ranges from +1.5 D to
+3.5 D.
• Presbia announced in November that the FDA had
given conditional approval to begin a Phase II trial of
the inlay.
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Slide 21
PRESVIA FLEXIVUE MICROLENS
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• Placed in the nondominant eye of a patient who is emmatropic in
both eyes
• Creates a slight myopic shift and a mild multifocal effect in the
implanted eye.
•
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Creating a small amount of monovision.
• A mixture of a little monovision and multifocality, very welltolerated.
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Slide 22
ADVANTAGES OF FLIXIVUE LENS
•
The main advantage the Flexivue has compared to the other
inlays is its more physiologic approach to correcting near vision.
•
Unlike the pinhole mechanism of action used by the Kamra inlay,
it provides an optical correction depending on the refractive
defect present,” he says.
•
Does not have issues regarding distribution of nutrients, which is
a factor with Raindrop and Kamra inlays.
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Slide 23
FLEXIVUE MICROLENS
• It is advised to do a contact lens mono vision
trial with a +1.50 contact lens in the nondominant eye prior to surgery. it gives the
patient the opportunity to experience the
controlled monovision the inlay produces
• FDA-approved Phase II clinical studies are just
starting.
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Slide 24
FLEXIVUE MICROLENS
•
Small Cohorts with positive results
•
Limited published research, nothing published in peer-reviewed
journals
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Prospective study 47 emmatropes with inlay implanted in nondominant eye
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UCNVA 20/32 or better in 75% of eyes at 12 months
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UCDVA unaffected
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Decreased contrast sensitivity
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Patient satisfaction and level of spectacle independence was
high
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Slide 25
FLEXIVUE MICROLENS (PRESBIA)
•
Inlay provides distance vision through a plano central zone that is
surrounded by a ring of varying add power for near vision, similar
to a multifocal contact lens or multifocal IOL.
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3.0 mm diameter lens with UV blocker
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1.5 mm opening in the center to facilitate flow of fluid nutrients
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Plano central zone, peripheral refractive zone with add power
from +1.25 to +3.50 D
•
Cosmetic appearance of inlay not of concern, as in KAMRA
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Slide 26
RAINDROP NEAR VISION INLAY
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REVISION OPTICS INC.
• Clear Hydrogel Lens
• Very small diameter
optics
• Hyperprolate shape
designed to reshape
the anterior corneal
curvature
• Enhances near and
intermediate vision via
multi-focal affect
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Slide 27
REVISION OPTICS’ RAINDROP
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Slide 28
RAINDROP INLAY
•
Formerly known as PresbyLens in the U.S. and Vue+ in Europe
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2mm diameter inlay is made of medical-grade hydrogel plastic similar to
that used for soft contact lenses and has optical characteristics that are
almost identical to the human cornea, according to the company.
•
The inlay improves both near and intermediate vision, as demonstrated
by a study involving 38 people who received the Raindrop Near Vision
implant in their non-dominant eye
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The Raindrop Near Vision corneal inlay is placed within the cornea under
a LASIK-style flap. When in position, the inlay changes the curvature of
the cornea so the front of the eye acts much like a multifocal contact
lens.
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The inlay has no power.
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Slide 29
RAINDROP INLAY
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Effective in a variety of situations, including bilateral implantation in hyperopic
patients.
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23 hyperopic subjects implanted, non-dominant eye first then 6 months later in
the dominant eye.
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Near vision improved from LogMar 0.54 to -0.04. Distance and intermediate
vision also improved and remained stable (article doesn’t state by how much)
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Bilateral implantation improved near vision by one line of acuity
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80% of bilateral subjects were 20/20 or better at all distances at follow up visits
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9 months post op all subjects (N=23) were satisfied with their vision
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Very Important to trial with multi-focal contact lenses to see if they adapt well
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Slide 30
CONTRAINDICATIONS FOR INLAYS
•
•
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Previous ocular surgeries
Any ocular pathology,
• Keratectasia
• Corneal degeneration
• Severe blepharitis
• Retinal disease
• Glaucoma
• Cataract
• Topographic irregularities
• Severe dry eyes – treat aggressively prior to surgery
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Slide 31
DISADVANTAGES OF INLAYS
• All of them reduce distance vision to some degree.
• Trade-off for improved reading vision
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• All of them cause some night glare
• Using an inlay requires a compromise in distance
vision.
• Nondominant eye in a patient who is a good adapter
usually does well
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Slide 32
DISCLOSURE
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The information in this lecture was found on:
http//www.reviewofophthalmology.com/content/t/c
ornea/c/46512/#sthash.CwNwW9Wz.dpuf.
Inlays and Presbyopia: The Next Froentier
http//www.allaboutvision.com
FDA web-site
Medscape.com FDA Panel Delivers Mixed Verdict on
KAMRA corneal inlay by Mirian E. Tucker June 9,
2014
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Slide 33
U.S. TRENDS IN REFRACTIVE SURGERY:
2014 ISRS SURVEY
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R I C H A R D J . D U F F E Y, M D
D AV I D L E A M I N G , M D
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R E F R A C T I V E S U B S P E C I A LT Y D AY
CHICAGO: OCTOBER 17, 2014
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Slide 34
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2014 SURVEY
Sixth year of ONLINE*** Survey
E-mailed to 1022 U.S. ISRS members; 486 Opened
Eighteenth year of refractive data collection overall
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15% response rate of the membership’s opened e-mail
requests analyzed by October 8, 2014.
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Alphabet soup of refractive surgery including corneal and
lens-based surgeries, premium IOLs, and FS cataract
surg.
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DUFFEY/ LEAM ING 2014
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Slide 35
PREFERRED SURGERY FOR A 30 YO
-10.00 DIOPTER MYOPE
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* 40% LVC
50
43
45
40
35
27
30
'05
'08
25
20
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'11
13
15
'12
11
10
'13
3
5
1
'14
0
Never
Surface
Ablation
LASIK
RLE
P-IOL
WAIT
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DUFFEY/ LEAM ING 2014
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Slide 36
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EXCIMER LASER MOST COMMONLY USED
70
50
'97
60
'00
44
'06
*
40
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'03
50
'09
30
'10
20
'11
'12
10
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'13
'14
0
VisX
Wavelight
B and L
Schwind
6
0
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DUFFEY/ LEAM ING 2014
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Slide 37
FLAPMAKER MOST COMMONLY USED
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* 71% femtoflaps
52
60
'98
50
'00
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'04
40
'07
30
'10
6
'11
20
11
8
10
0
10
5
4
0
B-L
Moria
Amadeus
'12
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'13
1
'14
Nidek
B-D
Intralase
Ziemer
Other FS
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DUFFEY/ LEAM ING 2014
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Slide 38
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COMANAGEMENT
80
70
'00
60
'04
50
'07
55
'10
45
40
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'11
30
'12
20
'13
10
'14
11
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0
Yes
No
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>50%
DUFFEY/ LEAM ING 2014
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Slide 39
PREFERRED FLAP THICKNESS
(WHEN NO OTHER CONSTRAINTS)
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68
70
60
'04
50
'07
40
30
'10
30
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'11
20
'12
10
'13
1
0
80
1
100
120-130
'14
150-160
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DUFFEY/ LEAM ING 2014
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Slide 40
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MINIMUM RESIDUAL STROMAL BED
THICKNESS REQUIREMENT FOR LASIK
* 64% at 275 microns or greater
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80
'04
70
'07
60
'08
50
'10
40
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'11
36
34
30
'12
20
23
'13
10
'14
0
225
1
200
0250
275
4 350
325
1
300
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DUFFEY/ LEAM ING 2014
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Slide 41
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TOTAL CASES OF POST LASIK ECTASIA
AS THE PRIMARY SURGEON IN CAREER
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60
50
'04
40
* Slight Growth Rate
'06
32
30
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'10
'11
20
17
19
'12
10
11
7
6
'13
6
3
0
0
1
2
3
4
5
'14
6 to 10
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>10
DUFFEY/ LEAM ING 2014
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Slide 42
MINIMUM CENT. CORNEAL PACHYMETRY FOR LASIK
(ALL OTHER PARAMETERS NORMAL)
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49
50
* 73% OK with 480 or less
45
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40
35
'05
30
'08
26
'10
25
'11
20
'12
15
11
13
10
'13
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'14
5
1
0
0
540 microns
520
500
480
460
no limit
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DUFFEY/ LEAM ING 2014
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Slide 43
TOTAL LVC VOLUME IN ISRS (X1000)
600
549
500
428
'08
'09
'10
'11
'12
'13
'14
400
300
200
121
100
0
Surface Ablation
DUFFEY/ LEAM IN
G 2014
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LASIK
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Total LVC
*22% Increase in Total LVC from 2012-13.
*Ratio of PRK / Total LVC remained
at 22% over past four years.
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Slide 44
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2014 ISRS SUMMARY
Thinner flaps dominate: 100 micron or less flaps are
favored by 68% of surgeons (up from 12% in ‘04).
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Preferred RSB thickness is stable: 34% think 250 microns
is adequate, but 65% recommend 275 microns or more.
New post-LASIK ectasia cases show a slight rise in rate.
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DUFFEY/ LEAM ING
2014
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Slide 45
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2014 ISRS SUMMARY
During cataract surgery 68% of surgeons will offer to correct
astigmatism if it is 0.75 D or more; 97% if 1.25 D or more.
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LRI/AK preferred (91%) if K astigmatism <1.0D
Toric IOL preferred (77%) if K astigmatism > 1.12D
CXL offered by 23% of ISRS members surveyed in the U.S. (not
FDA-approved).
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DUFFEY/ LEAM ING 2014
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Slide 46
UPDATES ON REFRACTIVE SURGERY MED’S
We are changing
from Durezol to
Lotemax “GEL” BID
x7d then QDx7d
Besivance TID x 7d
Ilevro QD or
Nevanac TID x 5d
FOR PRK Patients
(harder to get now)
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Slide 47
LOTEMAX “GEL”- COUPONS AVAILABLE
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Slide 48
REMINDER
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Have your patient’s come in for Testing PRIOR to the surgery day
•
•
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Wavescans –
• patients can accommodate a lot and we have difficulty getting the scans. This
can significantly delay the surgery team and add more time your patient is at the
surgery center on their day of surgery.
• Small pupils can affect our ability to get wavescans and they may need to be
changed to conventional surgery. This can be avoided if testing is done prior to
the surgery day. We can use a diluted dilating drop to slightly open the pupil to
get the wavescans. The pupil CANNOT be dilated on surgery day.
Topographies –
• At times, a topography can make or break the decision of LASIK vs PRK. It is
much easier to discuss the procedural change with a patient PRIOR to their
surgery day. This allows them to schedule more time off work and start the
medications prior to surgery if switched from LASIK to PRK.
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It can SAVE AT LEAST AN HOUR OF TIME ON SURGERY DAY!
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