1. Therapeutic Contact Lenses for Ocular Surface Disease Lynette K. Johns, OD, FAAO, FSLS, FBCLA

2. Disclosure Clinical and education consultant for Bausch + Lomb Boston GP Division Adjunct Assistant Professor at the New England College of Optometry

3. Overview Dry eye classification Indications for bandage soft contact lenses Indications for scleral lenses Quality of Life Long-term management Limitations of CL and Scleral Lenses Supplemental treatments

4. International Dry Eye Workshop Expert committee including clinicians and clinical scientists Defined and classified dry eye disease Epidemiology Diagnosis, monitoring, treatment and management Research and clinical trials 4

5. Dry Eye Disease Multifactorial Tears Ocular Surface Symptoms Discomfort Visual Tear Film Instability Associated Features Increased Tear Osmolarity Inflammation of Ocular Surface

6. Dry Eye Disease Aqueous deficient Sjogren’s syndrome Non-Sjogren’s (age related) Evaporative Meibomitis/Posterior Blepharitis Environmental Contact lens related Post-refractive surgery Allergic keratoconjuntivitis Blink abnormalities

7. Dry Eye and Ocular Surface Disease : Classification From 2007 report of International Dry Eye WorkShop (DEWS) Ocular surface 2007; 5 65-198.

8. EarlyTimeline of Contact Lenses 1 st century A.D. Celsus applied honey soaked linen to conjunctiva s/p pterygium removal 1888-1889 Fick, Kalt and Muller report using glass scleral lenses 1960 First publication of soft hydrogel polymers for biologic use (Wichterle O, Lim D: Hydrophilic gels for biologic use. Nature 185: 117-118.) 1963 Fredrick Ridley reports a review of 3,000 scleral fits over 13 years. (Ridley, F. Scleral Contact Lenses: Their Clinical Significance Arch of Ophthal 70: 740-745) 1970 First report of bandage soft contact lens use (Gasset AR, Kaufman HE: Therapeutic uses of hydrophilic contact lenses. Am J Ophthal 69: 252-259.) 1971 first soft contact lens was FDA approved 8

9. Therapeutic Soft Contact Lenses 9

10. Therapeutic Indications of Contact Lenses Protection from the lid Trichiasis Distichiasis Keratinized lid margins

11. Therapeutic Indications of Contact Lenses Protection from exposure Bell’s /CN VII Palsy Acoustic Neuroma Möbius syndrome s/p Blepharoplasty Orbital Disease Neurogenic & Mechanical Exposure

12. Therapeutic Indications of Contact Lenses Keratoprosthesis Type 1 Lubrication of corneal graft host Protection from ulceration

13. Re-epithelialization http://www.visiomed.co.za/prk.php Persistent Epithelial Defects Post-operative protection Therapeutic Indications of Contact Lenses

14. Pain Relief Filamentary Keratitis Bullous Keratopathy Post-operative

15. Piggyback Therapeutic Contact Lenses MLADEN ANTONOV/AFP/Getty Images 15

16. Piggyback Contact Lens system Therapeutic Indications of Contact Lenses

17. FDA Approved Silicone Hydrogel Bandage Contact Lenses Lotrafilcon ABalafilcon A AIR OPTIX® NIGHT & DAY® AQUA CIBA VISION® Approved 2003 BC 8.4, 8.6 Dia 13.8 Dk 140, 24% H 2 O PureVision™ Bausch + Lomb Approved 2005 BC 8.3, 8.6 Dia 14.0 Dk 91, 36% H 2 O Senofilcon A ACUVUE® OASYS® VISTAKON® Approved 2007 BC 8.4, 8.8 Dia 14.0 Dk 103, 38% H 2 O

18. Therapeutic Scleral Lenses 18

19. Therapeutic Uses of Scleral Devices Vision Rehabilitation Protection from Lids Protection from Exposure Surface Lubrication Pain relief Re-epithelialization

20. Therapeutic Benefits of Scleral Lenses Initial PresentationAfter 4.5 hours scleral lens wear Constant Surface Lubrication

21. Improving Quality of Life Examples in Literature 21

22. Graft versus Host Disease Transplanted bone marrow/stem cells recognize recipient tissue as foreign Acute form within the first 90-100 days after transplant Affects skin, liver, mucosa, gastrointestinal tract Dry eye affects 50% patients who had allogenic bone marrow transplant

23. Graft versus Host Disease

24. Ocular Graft versus Host Disease Keratoconjunctivitis sicca Cicatricial lagophthalmos Conjunctivitis Corneal ulceration/melt Uveitis Ectropian Cataract Ogawa Y, Kuwana, M. Dry eye as a major complication of graft-versus-host disease after hematopoietic stem cell transplantation. Cornea 2003 (22) suppl. 1 S19-27

25. Ocular Surface Disease Index 12 question validated self-administerred psychometric tool 3 subscales ▫ Ocular Symptoms ▫ Visual Function ▫ Environmental Triggers Can be used as an endpoint in clinical trials Aids monitoring of treatment outcomes Available online via ALLERGAN Scoring OSDI © = (sum of scores) x 25 (# of questions answered) Schiffman R, et al. Reliability and validity of the Ocular Surface Disease Index. ArchOphthalmol 2000;118:615-621.

26. Ocular Surface Disease Index Scoring Normal Mild Moderate Severe 0-12 13-22 23-32 33-100

27. Soft Contact Lenses and cGVHD Eye & Contact Lens 33(3): 144–147, 2007 Focus NIGHT & DAY® n = 8 Continuous wear x 7 days over 1 month Improvement in VA Reduction in OSDI from 77 to 31 Schirmer’s and Staining remained unchanged

28. Scleral Lenses and cGVHD Boston Scleral Lens n = 9 Retrospective review Reduction in OSDI from 81 to 21 after 2 weeks Further reduced to 12 after 1 – 23 months Biology of Blood and Bone Marrow Transplantation. 13: 1016-1021. 2007

29. Scleral Lenses and cGVHD Eye & Contact Lens 2008 34(6): 302–305. 2008 Cornea 2007 (26) 10: 1193-1195 n = 5 retrospective review 2007 4-14 month follow-up Improvement in VA Subjective improvement in symptoms n = 33 retrospective review 2002 -2005 Survey regarding pain (52 % reduction), photophobia (63% reduction), quality of life (73 % improvement) 22 wearing devices for 3 months – 2 years

30. Long-Term Management 30

31. Management of Recurrent Corneal Erosions Recurrent epithelial erosions Associated with trauma and anterior corneal dystrophies Characterized by ▫ Pain (worse in mornings) ▫ Injection ▫ Tearing ▫ Photophobia 31

32. 32 Management of Recurrent Corneal Erosions

33. Treatment of Recurrent Corneal Erosions Hyperosmotic agents Lubricants Bandage contact lenses Tetracyclines Superficial keratectomy Anterior stromal puncture Phototherapeutic keratectomy 33

34. Cornea (30) 2: 164-166. 2011 Retrospective review recalcitrant RCE n = 12 Bandage soft CL worn for 3 months (replaced every 2 weeks) with antibiotic prophylaxis 75 % of patients had no recurrence of RCE after 1 year Management of Recurrent Corneal Erosions

35. Randomized (unmasked) Controlled Study n = 29 Bandage soft CL worn for 3 months (replaced every 30 days) Ocular Lubricants (Lacrilube, Celluvisc) QID for 3 mos No difference in recurrence between groups. CL provide better initial comfort Cornea (32) 10: 1311-1314. 2013

36. Management of Persistent Epithelial Defects Photodocumentation Extended wear of scleral device Daily monitoring Antibiotic prophylaxis Daily disinfection of device and replenishment of fluid Longstanding PED’s can be managed with exchange of 2 devices q12 hours Weekend monitoring DOCUMENTATION!!!!!! 36

37. 10/25/2007 10/27/2007 11/05/2007 Management of Persistent Epithelial Defects

38. Corneal Perforation: Symptoms, Signs Symptoms Pain Impaired vision “Excessive tearing” Signs Flat Anterior Chamber Positive Seidel Sign (independent or with pressure) Iris Prolapse Causes Infectious Autoimmune Trauma

39. Cases 39

40. 56 y.o. F referred for scleral lenses for exposure keratitis and lagophthalmos Blepharoplasty #1 at age 32 OU UL & LL, revision 4 lids, hard palate graft, canthoplasty, hard palate grafts removed, soft palate grafts, soft palate graft removal, cheek lifts, punctal cautery x4 Total 38 facial and oculoplastic procedures Systemic history of Systemic Lupus Erythematosus, Fibromyalgia, Migraine Systemic meds: Namenda, Verapamil, Zolazepam, Vicodin Ocular Surface Disease Case 1

41. Ocular Meds: Tobradex 2x/week OU, Lacrilube OU qhs, Vigamox prn— “when eye is red” Chief complaint: dryness and pain OS>OD, inability to close OS, light sensitivity soft contact lens intolerant VA entering (specs): OD: 20/25-2 OS: 20/20 7 th nerve paresis, lagophthalmos, 2+ PEE (Oxford staining scale) TBUT: OD: 8 seconds OS: 7 seconds Schirmer’s: OD: 9 mm, OS: 7 mm Fitting goals: 1. Support ocular surface, 2. Improve comfort. 3. Improve vision Fit OU with scleral devices OD: 20/20 -2 OS: 20/15 -2 No corneal or conjunctival staining after 6 hours Case 1

42. 61 y.o. F referred for PROSE treatment for cicatrizing conjunctivitis and dry eye (x 10 years) associated with ocular cicatricial pemphigoid Systemic meds: Prednisone 5 mg q.o.d., Methotrexate injection 20 mg/week, Doxycycline 200 mg/day Ocular Meds: Restasis BID OU Past ocular treatments: Punctal plugs x4, cautery inferior OU, bandage contact lenses Chief Complaint: Pain, Dryness, Photophobia Ocular Surface Disease Case 2

43. Case 2 Entering VA (specs): OD: 20/40 OS: 20/40-2 Superior mild injection OD, inferonasal symblepharon OS Bilateral 1+ PEE (Oxford grading scale) Schirmer’s: OD: 7 mm, OS: 3 mm Fitting goals: 1. Improve Comfort, 2. Improve vision Fit and dispensed OU with VA 20/25 OD and 20/30 +1

44. Case 2 September 2005 OD: 16.5 OS: 16.5 May 2006 OD: 18.0 OS: 18.0 October 2007 OD: 18.0 OS: 18.0 April 2008 OD: 17.5 OS: 18.0 November 2008 Bandage soft CL OU

45. Example conditions and considerations Sjögren’s syndrome Increased risk (44x) for Mucosa-Associated Lymphoid Tissue (MALT) lymphoma—non Hodgkin’s lymphoma Scleroderma Handling Issues Neurotrophic Keratitis Redness is the patient’s only cue something is wrong Requires a near-flawless scleral fit Retinal surgery Scleral device diameter and haptic issues Limit impingement and aggravation of irregular conjunctiva Patch graft for perforation Visual rehabilitation

46. Ocular Surface Disease Case 3 61 y.o. F referred for resurfacing PED 1 month s/p patch for perforation 3 eye surgeries in prior 6m s/p Phaco CE, PCIOL s/p PPV/AFx/EL/16% C3F8 s/p PK Patch graft for descemetocele Secondary Sjögren’s syndrome Neurotrophic cornea ? Stem cell deficient

47. Case 3 Current TX by specialist : Vigamox QID PF Pred Forte BID Serum Tears q2h Doxy 50 mg p.o QD Bandage CL

48. Case 3 Re-surfaced after 6 days continuous wear and Vigamox in the device

49. Figure 2 a bc d Novel Applications- Drug Delivery Keating A., Jacobs D. Anti-VEGF Treatment of Corneal Neovascularization. The Ocular Surface. 2011 9 (4): 40-51.

50. October 2007 1w after continuous then daily wear of Boston Ocular Surface Prosthesis VA =CF 6’ March 2008: VA: 20/400 s/p 3 months topical Avastin in BOSP, suture removal, systemic steroid. ?PK for vision Case 3

51. July 2011 s/p PKP January 2011 VA 20/50 Overnight wear with device and one drop Vigamox. Resurfaced in 24 hours Case 3

52. Limitations 52

53. Limitations of Soft Contact Lenses Lens retention Desiccation Inability to correct irregular astigmatism Dependency on doctor for applications Microbial keratitis

54. Limitations of Scleral Lenses Daily wear Surface Debris Chamber debris Bubbles Suction Handling Microbial Keratitis

55. Microbial Keratitis: Risk for both soft lenses and scleral devices

56. Lens Management Considerations Soft Lenses & Scleral Lenses Depends on patients condition Application and removal Overnight wear? Prophylactic antibiotic? Close management

57. Soft Lens Studies that we discussed GVHD: ▫ Continuous wear x 7 days ▫ 1 month ▫ no antibiotic RCE: ▫ Continuous wear x 2 Weeks ▫ 3 months ▫ Antibiotic prophylaxis

58. Supplemental Management 58

59. Daytime Management with Lenses/Devices  Lubricants over lenses  Medications with lenses  Refreshing lenses  Punctal plugs  Moisture goggles

60. Nighttime Management: To sleep or not to sleep in the lens/device? Overnight ointment Tape tarsorrhaphy Nighttime goggles

61. THANK YOU! johnsl@neco.edu