Download Update on Scleral Lenses: A Review of Recent Literature

1/18/2017
Update on Scleral Lenses:
A Review of Recent Literature
Disclosures
• Mindy Toabe: Essilor
• Muriel Schornack: Advisory Board, Bausch + Lomb
Mindy Toabe, OD, FAAO, FSLS
Muriel Schornack, OD, FAAO, FSLS
Global Specialty Lens Symposium
Las Vegas, NV
Thursday, January 26, 2017
Objectives
Introduction
• Define study designs in peer-reviewed literature in the field of scleral
lenses
• Review current literature regarding scleral lens prescription and
management
• Discuss emerging areas of interest in the field of scleral lenses
• Suggest topics for future study
Overview of Literature
• Case reports/case series
• Retrospective reviews
• Prospective observational studies
• Reviews of systemic/ocular disease
• Reports (theoretical/clinical) of scleral lens effects on
anterior segment structures
• Miscellaneous reports
A Review of Recent Literature
Retrospective
3%
Other
10%
Review of
Ocular and
Systemic
Disease
15%
Observation/Evalu
aiton of Ocular
Surfce Structure
23%
Case
Reports/Series
[PERCENTAGE]
Prospective
19%
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Case Reports/Case Studies
Through 2014
Stevens–Johnson syndrome
Chronic graft vs. host disease
Exposure keratopathy
Neurotrophic keratopathy
Corneal dystrophy/ degeneration
Cicatrizing conjunctivitis
Persistent epithelial defects
Sjogren syndrome
Congenital corneal
Hypoanesthesia
Visual rehabilitation/corneal irregularity
Primary corneal ectasia
S/P penetrating keratoplasty
S/P refractive surgery
Corneal scarring
Correction of refractive error
Aphakia
High ametropia (nonaphakic)
Single Case Reports
Gupta, N., Ganger, A. Keratoglobus: a close entity to megalohthalmos. SpringerPlus 2016
2015-2016
CASE REPORTS
Post-LASIK ectasia with ICRS
Aniridic keratopathy
Refractory dry eye
Keratoglobus
• Comparison of how keratoglobus closely resembles buphthalmos and anterior megalophthalmos.
• VA improved from 20/60 to 20/30
Yuksel, E., Bilgihan, K., et al. The Management of Refractory Dry with Contact Lens. Eye Cont Lens 2016
• Healing observed by corneal findings and through an improvement in the patient’s quality of life.
CASE SERIES
Keratoconus (crosslinking, ICRS)
Pellucid marginal degeneration
S/P penetrating keratoplasty
Chronic graft versus host disease
Stevens–Johnson syndrome (corneal ectasia, toxic
epidermal necrolysis)
Exposure keratopathy
Keratoconjunctivitis sicca
Post-LASIK (complications, irregular cornea)
Dry eye disease
Aphakia
Retrospective
Asena, L., Altinors, D. Clinical outcomes of scleral Misa
lenses for visual rehabilitation in patients with pellucid
marginal degeneration
CLAE 2016
Rathi, V., Dumpati, S., et al. Scleral contact lenses in the
management of pellucid marginal degeneration
CLAE 2016
• Visual acuity improved log MAR 0.45±0.31 to 0.05±0.08
• 3 patients developed hydrops within the first 3 months
Post-LASIK Complications
Porcar, E., Espana, E., et al. Post-LASIK Visual Quality
With a Corneoscleral Contact Lens to Treat Irregular
Corneas
Mian, S., Agranat, J., Jacobs, D. Prosthetic Replacement of
the Ocular Surface Ecosystem (PROSE) Treatment for
Complications After LASIK
Eye Cont Lens 2015
Eye Cont Lens 2016
• VA improved from log MAR 0.14±0.03 to 0.01±0.06
• 84% improved BCVA
• Total HOAs improved from 1.09±0.26 to 0.24±0.14
• Primary indications: ectasia (n=23, 53%), optical
aberrations (n=14, 32%), dry eye (n=4, 9%) and
neuralgia (n=3, 7%)
• No statistically significant different in HOAs VA, or
SVQ after 1 year
• 71% had LASIK between 1998-2000 including every
patient with aberrations (1992-2007)
• 86% Hx of CL intolerance
Kramer, E., Boshnick, E. Scleral lenses in the treatment of post-LASIK ectasia and superficial neovascularization of
intrastromall corneal ring segments. CLAE 2015
• After successful scleral lens fitting OU with a Hx of crossing-linking OD, progressive fibrosis and NV
of the inferior ICRS in the left eye resulted in removal of the ICRS and a successful refitting of OS
resulting in VA 20/20 and ocular protection.
Retrospective
Prospective
• 25% (3 pts) abandoned wear due to I&R and less gain of
lines
• long term scleral lens treatment is an option to maintain a healthy ocular surface and visual
function in eyes with aniridia caused by LSCD.
• Early treatment may be beneficial in preventing stromal scar formation.
Penetrating Keratoplasty
Pellucid Marginal Degeneration
• VA improved from 0.42±0.15 Snellen to 0.75±0.15 with
mean gain of 3.3 lines
Kojima, T., Hasegawa, A., et al. Five-Year PROSE Treatment of Aniridic Keratopathy. Optom and Vis Sci 2016
Prospective
Barnett, M., Lien, V., et al. Use of Scleral Lenses and
Miniscleral Lenses After Penetrating Keratoplasty
Alipour, F., Behrouz, M., Samet, B. Mini-scleral lenses in the visual
rehabilitation of patients after penetrating keratoplasty and deep
lamellar anterior keratoplasty
CLAE 2015
Eye Cont Lens 2016
• 39.6 % BCVA of 20/20 (19 eyes), 91.7% BCVA of
20/40 or better (44 eyes) with mean BCVA of
20/25 and mean gain of 2 lines
• Quality of vision reported “good” in 70.8%, 72.9%
reported “comfortable”
• Subjective complaints: difficulty with I&R (14
eyes), haze, blurriness or halos (11 eyes), excessive
tear debris (11 eyes), discomfort (3 eyes)
• 35.4 % (13 patients/17 eyes) discontinued wear
due to I&R (8 eyes, 42.1%), dissatisfied with vision
(4 eyes, 21.1%) and discomfort (2 eyes, 10.5%)
• Graft rejection (6 eyes, 5 pts) with 3 eyes resuming
lens wear and no MK
• Subjective perception of vision was a factor in
continued lens wear
Mean visual acuity improved from 1.05 (SD:0.54) to 0.17
(SD: 0.19) log MAR
• No graft complications, only prolapse, hyperemia or
intolerance
•
Exposure Keratopathy
Chronic Graft vs Host Disease
Chahal, J., Heur, M., Chiu, G. Eye &
Contact Lens 2016.
Theophanous, C., Irvine, J., et al. Biol Blood
Marrow Transplant 2015
• VA improved from 56.54±29.75 to
24.98±21.23
• OSDI improved from 56.54±29.75
to24.98±21.23
• Corneal staining decreased from
2.17±0.84 to 0.64±0.70
• Scleral lens can serve as an alternative
to lid surgery
• VA improved from 72.6±20.1 to
21.1±14.9
• OSDI improved from 72.6±20.1 to
21.1±14.9
• 84% (66 of 79 eyes) showed
decreased corneal staining
• Complete healing of 9/9 eyes
filamentary keratitis( 9/9 eyes) and
epithelial defects (3/3 eyes)
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Stevens Johnson Syndrome
Papakostas, T., Le, H., et al. Am
Academy Ophthalmol 2015. (SJS/TEN)
• VA improved from 0.48 logMAR to
0.096 logMAR
• visual function scores (VFQ-25)
increased from 48 to 72 points
• NI in self reported general health
Saeed, H., Kohanim, H., et al. Am J
Ophthalmol 2016. (SJS with ECT)
• VA improved from 1.0 logMAR to 0.17
logMAR
• ECT occurs at a higher-than-expected
rate with SJS
• Contributory factors may include
corneal microtrauma and MMPs
• 64% fit with 18 month follow
up; failure rate was 36%
• 56% improved by 2 or more
lines; BCVA at baseline was
0.44logMAR (20.63) vs 0.16
logMAR (20/25)
• Comfort: 8.5 ±1.9, Visual
quality: 7.5 ± 2.2, Handling: 4.8
± 2.4 (0 best score), Wear time:
9.2 ± 2.8 hr
• No complications in 96% (23
pts/39 eyes): 1 complication:
corneal graft swelling
Eye Cont Lens 2016
What Are the Effects of Scleral Lens Wear On:
Br J Ophthalmol 2015
• Primary indication OSD (64 pts) followed by distorted corneal surface (57 pts)
• Continued device wear was 73.6% (89/121); Discontinued wear was 26.4%
(32/121)
• Continued device wear with distorted cornea (84%) compared with OSD
(64%), Wearing rate of 75% with GVHD compared with other OSD
• NEI-VFQ scores increased at 6 months with no decline at 5 years
• Higher NEI-VFQ scores at 5 years for those wearing device then those not
wearing
• Improved VA is associated with continuation of wear at 5 years
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Tear film biomarkers
Corneal curvature
Corneal, conjunctival, episcleral, scleral thickness
Optics and higher order aberrations
Intraocular pressure
Ocular surface temperature
CLAE 2015
Optom Vis Sci 2016
• 26 pts split into 2 groups: ICRS and KCN s ICRS
• Both groups: No change to Schirmer test and TBUT, decreased OSDI
scores and osmolarity (303 to 296 mOsm/l), increased MMP-9 (ICRS
>KCN s ICRS)
• KCN s ICRS group had lower concentration of Ap4a
• ICRS group had no change to Ap4a
• Ave Corneal curvature was
flatter (Ksteep 0.7D lower, Kflat
0.5D lower, Kmax1.1D lower)
• Ave pachy was ±2.5% higher
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• Significant tissue thinning in all
quadrants after 3 h ( mean
decrease in thickness -24.1 ±
3.6) /did not return to baseline 3
h after lens removal (-16.9 ± 1.9)
• Superior quadrant had largest
tissue compression (-49.9 ± 8.5)
and lens landing zone ( scleral
spur (-48.2 ± 5.7)
• 70% of compression occurred
with conjunctiva and episclera
CLAE 2015
Ophthalmic Physiol Opt 2016
• Superior (nasal) mid-peripheral flattening (up to 0.08± 0.04 mm)
especially with East Asian participants causing increased ATR
astigmatism (up to 0.50D)
• Decreased higher order aberrations (RMS -0.035 ± 0.046 ) including
horizontal coma, vertical coma and spherical aberration
Intraocular Pressure
Nau, C., Schornack, M. McLaren, J., Sit, A. Eye
& Contact Lens 2015
Mean central IOP (13.9 ± 3.1 mm Hg) in study eye
was not different from the control eye (13.9 ± 3.1 mm
Hg) or in the same eye before lens wear (13.6 ± 1.9
mm Hg)
Viewpint: Vincent, S., Alonso-Caniero, D.,
Collins, M. Clinical and Experimental
Optometry 2016Study various lens design upon
IOP
Mean increase 0.6 mmHg during lens wear
(peripheral scleral measurement) and mean
increase 0.5 mmHg immediately following lens
removal (central corneal measurement)
Eye Cont Lens 2016
KC-ICRS (n=13) and KC group (n=13)
• No difference in all temperature
points before and after scleral
lens wear
• No significant change in Schirmer
test and TBUT
How Does Design and Perception Relate to
Scleral Lenses:
• Scleral Lens Evaluation
• Patient Experience
• Fitting Characteristics
Optom Vis Science 2016
• Mean difference between
observed and AS-OCT was:
• 115.0 microns OD
• 42 microns OS
• Significant overestimation of
CCC
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Optom Vis Sci 2015
Optom Vis Science 2016
• No change in VA, wear time, and subjective tolerance
• 61% needed fit and/or power change
J Ophthalmic Vis Res 2016
• Mean UCVA 0.6±0.26 to BSVA 0.38 to BCVA 0.08±0.05 log MAR
• Total HOA decreased from 1.85±0.81 to 0.886±0.47
• Past experience of soft, hard and
hybrid designs with the majority
wearing corneal GP lenses
• Ave wear time was 14 hrs (range7-18)
• KC pts prefer comfort and vision while
experiencing less dryness with ScCLs
• Most experienced occasional midday
fogging
Toric Peripheral Curves
Eye Cont lens 2016
• Neither age or diagnosis affects ease
of scleral lens use
• Ave number of: devices 5.3 ± 2.4,
visits 11.8 ± 4.4, length of fitting
process 183.8 ± 30.5 days (6 months)
• Wear time: 4.0 ± 4.0 week 1 to 8.0 ±
4.4 week 2, full time wear 13.5 ± 11.8
days (2 weeks)
• I&R <5 min by week 5
• Difficulty: week 1 insertion 1.35 ±
0.61 removal 1.44 ± 0.50, score of 1 by
week 5 for insertion and week 6 for
removal
Ticak, A., Marsack, J., Koenig, D., et al. A Comparison of Three Methods to
Increase Scleral Contact Lens On-Eye Stability, Eye & Contact Lens 2015
3 stabilization methods provided similar
stability and simulated optical and visual
performance compared with a spherical
lens. Simple toric peripheral designed
lens can be used with wave-front guided
correction.
Review
• Ave settling was 62.8 after 8 hrs
with 80% occurred within 4 hrs
• 1.3% corneal swelling after 8 hrs
• Lower apical clearance settled
less compared with high vault
fits
Curr Opin Ophthalmol 2015
Outcomes
• efficacy measured by Improved OSDI, NEI-VFQ
scores, and VA
• No difference based on cause of DES
• Wear time is over 16h per day
• Predictors of success: 0.2 to 0.3 mm of corneal
vault, 0.1 mm of limbal clearance without air
bubbles
• Autologous serum tears together with scleral
lenses
• Use with severe DES in conjunction with more
aggressive treatment options
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Ocular Surface Structure:
Anatomy and Function
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Clinical observation
Development of measurement methods
Possible development of tools to allow for measurement
Validation of said tools
Collection (or identification) of baseline or control data
Collection of data over time
Reviews of Ocular Disease
Clinical Ophthalmol 2015
Clin Exp Optom 2015
Br J Ophthalmol 2016
Curr Opin Ophthalmol 2015
CLAE 2016
Reviews of Systemic Disease
Eye Cont Lens 2015
Evaluation of Ocular Surface
Structure/Function
• What do we THINK we know?
• What do we REALLY know?
• What do we NEED to know?
Bandage and scleral
contact lenses for ocular
graft-versus-host disease
after allogeneic
haematopoietic stem cell
transplantation
Elena I. Stoyanova, 1 Henny M . Otten,1,2
Robert Wisse,1 A niki Rothova3 and A njo
Riemens1
Acta Ophthal mol ogica 2015
Scleral Stiffness
Scleral Shape
• Studied post-mortem eyes
• Primarily interested in posterior
sclera, near lamina cribrosa
• Diabetes increases scleral
stiffness
• Scleral stiffness also increases
with age
BMC Ophthalmology 16(1): 176.
• 24 eyes
• Axial radius of
curvature defined
• Axial length, anterior
chamber depth, whiteto-white measurements
are useful parameters
for estimating ARC of
sclera
Journal of biomechanical engineering 137(7).
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Scleral Thickness
PloS one 10(7): e0132902.
Graefes Arch Clin Exp
Ophthalmol 253(9): 15751580.
• Measured scleral thickness
using anterior segment OCT
in 74 individuals< age 40
• 1 mm increments to 6 mm
from scleral spur in 8
meridians
• Assessed intra- and interobserver variability
• Mean scleral thickness was
725±46 microns
• SN meridian was thinnest,
inferior was thickest
• Sclera was thinnest at scleral
spur, thickest at 6 mm
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53 eyes (Caucasian subjects)
Age range: 18-92 (mean: 48.6 years)
Measured in 4 meridians (ST, SN, IN, IT) 2 mm from scleral spur
Statistically significant differences between quadrants
• 475±81 ST, 463±64 SN, 571±84 IN, 511±80 IT
• Resembles spiral of Tillaux
• Scleral thickness increases with age
Scleral and Conjunctival Thickness
Scleral and Corneal Thickness
• 111 healthy young participants
• Measurements acquired using
anterior segment OCT
• Younger subjects had thinner scleras
and thicker conjunctiva
J Cataract Refract Surg 41(5): 1073-1080.
Scientific reports 6: 33796.
Ophthalmic Physiol Opt 36(3): 279-289.
• 19 healthy young subjects
• AS-OCT measurements
• Significant diurnal variation
noted in both sclera and
conjunctiva
• Thickest immediately after
awaking
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Compared 51 eyes with keratoconus to 50 control eyes
Utilized Pentacam and AS-OCT to obtain measurements
Corneal thickness was decreased in subjects with keratoconus
No difference was noted in scleral thickness between groups
Identification of the Limbus
J Cataract Refract Surg 41(1): 186-192.
• Evaluates repeatability of measurements of corneal parameters using the Galilei
G4 system
• 25 eyes of 25 subjects measured
• 3 measurements taken of each eye
• Excellent repeatability of measures of corneal thickness
• No significant difference between corneal power assessment (total power, flattest
power, steepest power, astigmatism magnitude)
• Some variation in HOA assessment
Cont Lens Anterior Eye. 2016, in press
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Data collected on 4 young healthy patients
Eye Surface Profiler utilized
Image intensity transition does not correspond with topographic change
HVID may not be the best method for determining the position of the limbus when
fitting scleral lenses
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Cornea 35(6):2016
• 40 eyes of 40 subjects
• Assessed AC depth and white-to-white measurements
• Measurements were obtained with IOL Master, LenStar 900,
Pentacam HR, Visante OCT
• Two independent measurements obtained on each device
• All devices provided reliable and accurate measurements
Cont Lens Anterior Eye
39(2): 148-153.
J Cataract Refract Surg. 41 (2015)
• Compared intra-operator repeatability, inter-operator and
intersession reproducibility, and agreement between Pentacam,
Sirius, Galilea G3, and Visante AS-OCT
• Evaluated 71 eyes of 71 patients
• Found excellent intra- and inter-operator reproducibility
• ACD agreement was reasonable between all devices
Medical Contact Lens Fitting
Visser, E. S., et al.
(2016). "Objective
and subjective
evaluation of the
performance of
medical contact
lenses fitted using a
contact lens
selection algorithm."
Cont Lens Anterior
Eye 39(4): 298-306.
• Prospective, observational, non-randomized, non-comparative study
• 63 eyes of 47 patients
• Compared data from Pentacam (corneal elevation, thickness, density
and AC depth) to lens diameter and lens sagittal depth
• Positive correlation between lens sagittal depth and AC depth in
keratoconus
• No statistically significant correlations noted in dry eye patients
Scleral Lenses as Telescopes
Cont Lens Ant Eye 39 (2016)
• Assessed concentration of Ofloxacin in cornea, aqueous and vitreous in
rabbits after 4 hours of scleral lens wear
• Evidence of peripheral superficial keratitis was noted in treated eyes, but
not in control eye
• Arianpour, A., et al. (2015). "Wearable telescopic contact lens."
Applied optics 54(24): 7195-7204.
• Schuster, G. M., et al. (2015). "Wink-controlled polarization-switched
telescopic contact lenses." Applied optics 54(32): 9597-9605.
• First and second prototypes described
• Further development necessary for practical application
• Structural modification necessary to allow for safe wear
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What do we still need to learn?
How do scleral lenses affect the anterior segment?
• Scleral Lenses and Conjunctiva
• Thickness
• Structure
• Goblet cell density
• Scleral Lenses and the Cornea
• Topographic changes
• Corneal thickness/volume
• Corneal nerve structure and function
• Scleral Lenses and Intraocular Pressure
• Episcleral venous outflow
• Schlemm’s canal
Conjunctival Prolapse
Fluid Reservoir Debris
• Who is likely to
experience this?
• Are there long-term
negative consequences
related to this issue? If
so, what are they, and
how often do they occur?
• How can we minimize or
avoid entrapment?
What is the “ideal” fit?
What is it?
How can we measure it?
Who is likely to experience this?
Does this affect vision
(discrimination acuity, contrast
sensitivity, glare)?
• Does this have any negative
metabolic effects on the cornea?
• How can we prevent this?
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Lens Care and Wearing Schedules
• Lens Care
• Surfactant cleaners (removal of surface debris without damaging lens surface)
• Lens storage (preserved vs. non-preserved)
• Application solution
• Wearing Schedules
• As much as possible, or as little as possible?
• Mid-day removal?
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When should scleral lenses be used?
Corneal Irregularity
• Spectacles
• Hydrogels/silicone
hydrogels
• Corneal RGP’s
• Hybrids
• Piggyback systems
• Scleral lenses
Patient Selection
• Characteristics of successful patients
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Specific diagnoses?
Personality traits?
Physical characteristics?
Age?
Gender?
Expectations?
Entering visual acuity?
Degree of HOA?
Complications of Scleral Lens Wear
Ocular Surface Disease
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Lubricant drops
Punctal occlusion
Moisture chamber
glasses
Topical medications
Systemic medications
Bandage contact lenses
Conclusion
• Explosive growth in research
(quantity and quality) during the
past two years
• Specific areas of study are being
developed
• Variables that need to be
controlled are being identified
• Multicenter studies on outcomes
are not yet available
• There’s plenty of room for growth
in this area!
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