Melissa Barnett, OD, FAAO, FSLS, FBCLA University of California, Davis Eye Center  ABB  Ocusoft  Acculens  Paragon Bioteck  Alden Optical  Percept  Alcon  Science Based Health  Allergan  Scleral Lens Education Society  Anthem, INC  Shire  Bausch + Lomb  Sjogren’s Syndrome Foundation  Bruder  STAPLE program  Contamac  SynergEyes  CooperVision  Visioneering Technologies  JJVC Vistakon  Gas Permeable Lens Institute Scleral lenses are large diameter gas permeable lenses that rest beyond the limits of the cornea and extend onto the sclera. Popular Mechanics, 1948  Made from impression mold of eye  Difficult to make  Problem with hypoxia

www.college-0ptometrists.org  First used in late 1800s and early 1900s  Manufacturing process now more reproducible

 Modern scleral lenses . Don Ezekiel, O.D. . Ken Pullum, O.D. . Perry Rosenthal, M.D. Boston Scleral Lens www.sclerallens.org

 Corneal ectasias • Primary corneal ectasias . Advanced (notably decentered) keratoconus . Keratoglobus . Pellucid marginal degeneration • Secondary corneal ectasias . Post-LASIK . Post-PRK . Post-RK  Corneal transplants  Corneal degenerations or  Trauma dystrophies  Corneal scars . Salzmann’s nodular degeneration . Terrien’s marginal degeneration  Persistent epithelial defects  Severe dry eyes . Graft versus host disease . Sjögren’s syndrome . Stevens Johnson syndrome . Neurotrophic keratopathy  Neurotrophic Keratitis  Exposure Keratitis  Dry Eye Syndrome  Graft vs Host Disease  Steven Johnson Syndrome  Ocular Cicatricial Pemphigoid  Chemical Burns  Limbal Stem Cell Failure  Sjogren’s Syndrome  Persistent Epithelial Defect  Inflammatory conditions . Limbal stem cell deficiency . Ocular cicatricial pemphigoid  Neovascularization with hybrid lens designs  Poor comfort with traditional gas permeable designs  High refractive error  Corneas with significant edema from reduced endothelial cell count  Fuch’s corneal dystrophy  Glaucoma?

 Picot, C, Gauthier, AS, Campolmi, N, Delbosc B  J Fr Ophtalmol. 2015 Sep;38(7):615-9.

 Evaluated the improvement of QOL with scleral lenses in keratoconus or the treatment of astigmatism after penetrating keratoplasty ▪ Retrospective study ▪ Patients failed to adapt to RGP lenses ▪ QOL before and after scleral lens adaptation  47 patients (83 eyes) fit with scleral lenses on one or both eyes  56 eyes with KCN  27 post-keratoplasty eyes

 NEI-VFQ 25 scores with scleral lenses were significantly higher than those without scleral lenses.  Scleral lenses showed significant improvement in quality of life for patients who had failed or are intolerant to conventional rigid gas permeable contact lenses.  Scleral lenses are an alternative or a step prior to surgery ©2012 MFMER | slide- 24  63 year old Caucasian male  Referred by corneal specialist for a contact lens fitting both eyes  Vision not as clear for distance  Eyes irritated and dry at the end of the day  History of small diameter gas permeable contact lens wear since 1962 OD OS 20/40 PH 20/30 VA 20/25 PH 20/20-2 (with GPs) -6.50+0.50x065 20/60 Refraction -3.75+0.50x095 20/60 45.18 / 54.26 / 045 Pentacam 51.61 / 53.07 / 002 Irregular astigmatism Sim Ks Irregular astigmatism

505 Pachymetry 542

14 mmHg Applanation IOP 15 mmHg @ 1:22pm OD OS 1+ mgd L/L 1+ mgd

White and quiet Conjunctiva White and quiet

Fleisher Ring Cornea Fleisher Ring paracentral paracentral scarring scarring less than 1mm Deep and Quiet A/C Deep and Quiet

1+ nuclear and Lens 1+ nuclear and cortical sclerosis cortical sclerosis 0.40 C/D 0.30

Normal Macula Normal OD OS Scleral Lenses

Scleral Lens Parameters Scleral Lens Optimum Extra Optimum Extra OD 47.25 / -5.75 / 16.6 / OS 48.50 / -5.99 / 16.6 / 13.25 / 14.75 8.6 OZ / 13.25 / 14.75 Sag 4.88 Sag 4.88 20/25+1 VA 20/20-2 SOR pl SOR pl Binocular VA 20/20+1 Good central and Fit Good central and peripheral clearance peripheral clearance No blanching No blanching  Foggy vision after 4-5 hours of scleral lens wear  Solutions . Treat eyelid disease . Change solutions ▪ Hydrogen peroxide ▪ Add more viscous solution with lens application . On eye surface cleaning

X-Ray Vision Specialties, P.C. 2020 Sunnyview Blvd. Anywhere, USA 12345 Tel:(555) 555-5555 Fax: (555) 555-5556 I.M. Awesome, O.D. B. Mypatient, O.D.

Name:______Address:______Date:______

R 0.9% NaCl Inhalation saline for ophthalmic use Dispense : 1 box (100 count) 3 ml vials Sig: Use as directed with ocular prosthetic device ©2012

MFMER

| slide- Refills: ______29 NaCl 0.9% Inhalation LacriPure ScleralFil Solution (Menicon) (B+L)

No buffers, no preservatives No buffers, no preservatives Contains buffer, no preservatives

Off-label FDA approved FDA approved

Available in 3 ml or 5 ml vials 5 ml vials 10 ml vials

Available in box of 100 vials Available in box of 98 vials Available in box of 30 vials • Potential severe impact • On visual acuity • On convenience • Lenses removal and reapplication is inconvenient • Etiology • Fluid dynamics under a scleral lens • Attracts deposits in the reservoir if the clearance over the limbus is high enough • No tear exchange: debris accumulation over time  Mucin debris . Opaque, white, fluffy, small debris

 Management . Eliminate peripheral edge lift . Tighten peripheral curves Image credit Lynette Johns, OD . Add toric peripheries . Reduce wearing time . Lens removal and reapplication . Clean lens with an enzymatic cleaner or a sodium hypochlorite- potassium bromide-based system . Eliminate preservatives (use hydrogen peroxide based systems)  Atopic debris . Association between atopic disease and keratoconus1 . Diluted milk-like fogging

 Management Image credit Lynette Johns, OD . Lens removal and reapplication . Evaluate lens fitting relationship . Reduce excessive edge lift . Toric peripheries if edge lift is meridional . Topical mast cell stabilizers or “soft” steroids (monitor IOP and rule out infection with steroid use)

1. Harrison RJ, Klouda PT, Easty DL, et al. Association between keratoconus and atopy. Br J Ophthalmol. 1989;73:816-822.  Meibomian debris . Semi-transparent debris that appears like olive oil floating on water . May be refractile and a yellowish color

 Management Image credit Lynette Johns, OD . Carefully evaluate and treat the eyelids for any signs of meibomian gland dysfunction or blepharitis . Reduce excessive tear exchange by altering the peripheral curves . Lens removal and reapplication  Insertion Fluid . Adjunctive fluids? ▪ Preservative free artificial tears ▪ Autologous Serum ▪ Antibiotics ▪ What does the future hold  Nutrient?  Electrolyte rich?  Oxygenated?  Hypertonic? Credit John Gelles, OD, Review of Optometry, Mangan, Amazon, ContaPharm, Wyss

Slide credit John Gelles,OD  Symptoms  “hazy” or “misty” after 3-4 hours of lens wear  Possible causes . Poor wetting . Front surface deposits . Debris in the tear reservoir . Corneal edema  Important to ask about rainbows around lights, indicative of microcystic epithelial edema or Sattler’s veil  Patients may describe a sensation of heat  In severe cases, patients report migraine-like headaches  Practitioners should be hypervigilant about corneal edema, especially with corneal transplant patients  Dispense flashlight or penlight for hourly “rainbow checks”  Evaluate how many hours lens wear before the onset of fogging and/or rainbows

 If symptoms, remove the lens, clean and reapply immediately  If vision is clear on reapplication, the cause is more likely related to the lens / fit than corneal response Example of microcystic corneal edema in a failing graft that is retroilluminated from the reflection off an intraocular implant Image credit Contemporary Scleral Lenses: Theory and Application  Status post radial keratotomy both eyes three times  Corrected to +5.00  Underwent hyperopic LASIK  Wore soft contact lenses from 2000 - 2006  Then infection of incision of left eye  Treated for 4 months, healed  Now poor best corrected vision OD OS 20/50 VA 20/50-2 (CLs) 40.66/35.83/173 Topography 34.35/33.58/160

-14.00 20/60 Refraction -16.50 20/80 Poor endpoint Poor endpoint

584 Pachymetry 567

15 mmHg IOP 14 mmHg tonopen @ 11:00am OD OS

1+ mgd L/L 1+ mgd

White and quiet Conj White and quiet

16 RK scars K 16 RK scars (irregular), no (irregular), no visible visible LASIK flap, LASIK flap, iron lines iron lines along RK along RK incisions, incisions, 2mm 2mm optic zone, optic zone inferior neovascularization Deep and Quiet A/C Deep and Quiet

Clear Lens Clear 0.30 C/D 0.30

Normal Macula Normal Normal Peripheral Normal Retina  Scleral lens parameters  OD scleral lens / 7.11 / -17.75 / 15.4 / 8.0 / sag 4.63 20/25-2  OS scleral lens / 7.14 / -17.00 / 15.4 / 8.0 / sag 4.62 20/20-2 Binocular 20/20-2

 Prevalence is much higher among women  Aging is a risk factor  Sex hormones are key factors  Changing hormone levels / decreased androgens are contributory  50 year old Caucasian female  Interested in contact lenses for full time wear

 History of Sjögren’s Syndrome ▪ Diagnosed 3.5 years ago  Dry mouth  Ocular foreign body sensation  Intermittent red eyes  anti-Sjögren’-syndrome-related antigen A (anti-SSA/Ro) antibody positivity  focal lymphocytic sialadenitis with a focus score of at least 1 foci per 4 mm2  abnormal ocular staining score of at least 5 or a van Bijsterveld score of at least 4  Schimer’s test result of no greater than 5 mm per 5 minutes  an unstimulated salivary flow rate of no greater than 0.1 mL per minute  anti-SSA/Ro and sialadenitis items . Weight of three  Remaining three items . Weight of one  Individuals with signs or symptoms of Sjogren’s syndrome (SS) and who have a total score of at least 4 for the above items meet the criteria for primary SS.  New studies additional autoantibodies in Sjögren's Syndrome to . Salivary gland protein 1 (SP-1) . Carbonic anhydrase 6 (CA6) . Parotid secretory protein (PSP)  Occurred earlier in the course of the disease  Antibodies found in 45% of patients meeting the criteria for Sjögren's Syndrome who lacked antibodies to Ro or La

 SP-1, CA6 and PSP . Useful markers to identify patients with Sjögren's Syndrome at early stages of the disease . Useful markers to identify those that lack antibodies to either Ro or La  Wears glasses full time  History of weekly replacement contact lens wear  Discontinued contact lens wear due to dry eyes with contact lenses  Budget analyst  Computer and reading 8-10 hours / day  Medical history . Sjögren’s Syndrome

 Medications . Plaquenil 200 mg bid po (x 2.5 years)

 Ocular history . Dry eyes . Cyclosporine 0.05% bid OU . Preservative free artificial tears PRN (3x in past week) . Visine PRN (2x in past week)

 Family history . Mother – rheumatoid arthritis OD OS 20/20 VA 20/20-2 (glasses) 43.10 / 44.00 / 106 Pentacam 43.10 / 44.00 / 083 Sim Ks

-4.75 20/20 Refraction -5.50 20/20

542 Pachymetry 532

18 mmHg IOP 18 mmHg tonopen @ 3:42pm OD OS 2+ mgd, irregular lid margins L/L 2+ mgd, irregular lid margins

Trace hyperemia, 2+ NaF Conj Trace hyperemia, 3+ NaF stain stain nasal and temp nasal and temp 1+ nasal and temp LG stain 3+ nasal and temp LG stain Trace inferior PEK Cornea 3+ inferior PEK at 6:00 and Trace endopigment inferior 3:00 paracentrally Trace endopigment inferior paracentrally Deep and Quiet A/C Deep and Quiet

Clear Lens Clear 0.15 C/D 0.15 Normal Macula Normal Normal Peripheral Retina Normal Large-scale Genome-Wide Association Study (GWAS) study 3,334 Sjögren’s patients Non-Hodgkin lymphoma occurs in 5- ★ 10% of primary Sjögren’s patients  Sjögren Syndrome Foundation information  OCT of macula and 10-2 Humphrey visual field  Continue Cyclosporine 0.05% bid OU  Non-preserved Thearatears or Celluvsic artificial tears qid OU / PRN  Refresh PM ointment qhs OU / PRN  Good water intake  HydroEye Omega 3 fatty acids.  Discussed Moisture goggles  Avenova eyelid cleaner bid OU for two weeks, then daily OU  Warm compresses (discussed various options)

Study Design • Multicenter, randomized, double-masked study • 19 moderate to severe dry eye patients • Compared habitual scleral lenses and scleral lenses coated with Tangible® Hydra-PEG® • For 30 days each with a one week wash out period in between

Statistically significant improvements (p<0.05) seen with Tangible® Hydra-PEG® in: • Contact lens comfort (CLDEQ-8) • Dry eye symptoms (OSDI) and • Dry eye signs

Patient-reported improvements in comfortable lens wearing time and frequency of foggy vision (p<0.002 in both cases) were greater when wearing the coated lenses.

 Scleral lens education society video  Scleral Contact Lens Insertion, Removal, Troubleshooting and Lens Care  http://www.sclerallens.org/how-use-scleral-lenses  http://www.gpli.info Thank You!

Please feel free to contact me with any questions Melissa Barnett, OD, FAAO, FSLS, FBCLA [email protected]