Transcript Document

Role of a Sutureless Amniotic
Membrane Patch in
Restoring the Corneal Surface
Anterior Segment OCT Assessment
Roxana Ursea, MD
Matthew T. Feng, MD
The authors have no financial interest in the subject matter of this poster
Sutureless Amniotic Membrane Patch
*
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Superficial corneal erosion
Neurotrophic corneal epithelial
defect/inflammation
Recalcitrant corneal inflammation
Acute chemical/thermal burns
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↑ Corneal epithelialization
↓ Ocular surface inflammation
↓ Pain
†
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Acute Stevens-Johnson syndrome
Corneal transplant (to prevent high-risk
complication/rejection)
Socket/fornix/lid reconstruction (to
prevent lid/lash rubbing)
Severe bacterial keratitis
* AmnioGraft® (Bio-Tissue Inc, Miami, FL)
† ProKera® (Bio-Tissue Inc, Miami, FL)
Purpose
To evaluate the efficacy of sutureless, adhesiveless
AM patch in the treatment of corneal thinning with
and without epithelial defect using anterior segment
optical coherence tomography (AS-OCT)
Methods
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Retrospective noncomparative interventional case series
Setting: University of Arizona
Eight eyes (7 patients) received sutureless AM patch* from
June 2007 to May 2009 for corneal thinning
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With persistent epithelial defect (n = 4)
Without associated epithelial defect (n = 4)
Primary outcome measure: Minimum corneal thickness
measured by AS-OCT†
Secondary outcomes:
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Epithelial defect size, corneal surface, corneal clarity
Snellen BCVA, anterior segment inflammation
Pain, photophobia, side effects
* ProKera® (Bio-Tissue Inc, Miami, FL)
† Visante OCT® (Carl Zeiss Meditec, Dublin, CA)
Results
Pt.
Age
No.
Sex
Eye
Indication(s)
Etiology
Past Ocular History
Laser iridotomy,
cataract
1
74
F
OD
T, PED
2
75
M
OS
T, PED
Infectious
keratitis, corneal
abrasion
PKP rejection
3
73
F
OD
T, PED
Infectious keratitis
4
59
F
OS
T, PED
Infectious keratitis RA, corneal melt s/p
repair
5
57
F
OS
T
RA
Scleritis, dry eye,
corneal endothelial
dystrophy
6
66
F
OD
T
Dry eye, cataract
OS
T
Sjogren, RA,
scleroderma
OD
T
Infectious keratitis
7
56
F
Trauma, RD s/p
PPV c/b PBK
Cogan dystrophy,
pseudophakia
Prior Ocular
*
Surface
Treatment(s)
AT, FML,
Zaditor, abx
AT, Restasis, PF, Alphagan P
abx
Epithelial
Defect
(mm)
1.3 x 1.5
Defect
Duration
(m)
6
Haze
2.2 x 3
10
0.7 x 0.7
5
5.8 x 7
1.5
AT, abx, BCL
None
Fortified abx
None
Haze,
subepithelial
scar
Haze
AT, Restasis,
abx, Zaditor
None
Clear
None
N/A
None
Clear
None
N/A
Subepithelial
scar
None
N/A
Haze,
superior scar
None
N/A
Corneal scraping,
Corneal abrasion, dry PP, Restasis, AT,
autologous
eye, cataract
serum tears, PF,
abx
Ruptured globe
repair, dry eye,
pseudophakia,
trabeculectomy
Chronic
Corneal
Medications
Clarity
(Glaucoma)
Brimonidine,
Haze,
timolol
inferior scar
Muro, AT, Pred
mild, Zaditor,
abx
Lumigan,
Alphagan,
Cosopt
AS-OCT: With Epithelial Defect
Pt. 1
Pt. 2
Pt. 3
Before
After
AS-OCT: No Epithelial Defect
Pt. 5
Pt. 6
Pt. 7
Before
After
Results
Objective
Pt.
No.
Eye
ProKera
Epithelial
Duration
Defect
(d)
Corneal
Thickness
(um)
BCVA (Snellen)
Subjective
Conjunctival
Inflammation
Effect
Duration
(m)
Pain (0-10)
Photophob Followia
Up (m)
Post
0
Pre
+
Post
-
3.7
1
OD
+
16
Pre
370
Post
500
Pre
20/100
Post
20/70
Pre
Trace
injection,
trace
chemosis
Post
Quiet
Ongoing
Pre
8
2
3
4
OS
OD
OS
+
+
+
12
10
20
380
460
110
530
540
360
2/200
20/30
HM
2/200
20/30
HM
Quiet
Quiet
1+
injection,
trace
chemosis
Quiet
Quiet
Quiet
2
Ongoing
Ongoing
0
0
3
0
0
0
+
++
+
-
12
1.3
2
5
6
OS
OD
-
6
15
460
210
550
400
20/25 20/20
20/300 20/200
Quiet
Quiet
Quiet
Quiet
Ongoing
Ongoing
5
3
0
0
+
++
+
15
11.9
7
OS
OD
-
22
16
240
450
360
500
3/200 20/200
10/200 8/200
Quiet
Trace
injection
Quiet
Trace
injection
*
Ongoing
Ongoing
2
3
0
0
++
-
+
-
11.1
6
Corneal Thickness Over Time
With PED
No PED
After ProKera wear for a mean of 14.6 ± 5.2 days, corneal thickness increased 132
± 64 μm by AS-OCT within one to four weeks of treatment in eyes with PED and
within six weeks in those without defects
Duration of effect was at least 8.2 ± 5.3 months
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Epithelial Defect Size Over Time
Re-epithelialization occurred within one week in 75% of PED
Conclusions
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After ProKera wear for a mean of 14.6 ± 5.2 days, corneal
thickness increased 132 ± 64 μm by AS-OCT within 1 – 4 weeks
of treatment in eyes with PED and within 6 weeks in those
without defects
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Duration of effect was at least 8.2 ± 5.3 months
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Re-epithelialization occurred within one week in 75% of PED
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Associated inflammation, pain and photophobia all decreased
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ProKera is a convenient device that can easily be administered to
manage corneal thinning and PED
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AS-OCT was useful for quantifying ProKera’s clinical efficacy