corneal dystrophies & degenerations … symposium...corneal dystrophies ... is stromal puncture,...

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Contemporary Uses of Bandage Contact Lenses

Michael DePaolis, OD, FAAO

Flaum Eye Institute – UR Medicine

[email protected]

Therapeutic Bandage Contact Lenses

Questions for consideration

▪ What is the rationale for therapeutic bandage lenses?

▪ What is the future for drug delivery bandage lenses?

▪ What are the most common clinical indications?

▪ What about amniotic membranes and scleral lenses?

▪ What ancillary therapies are necessary?

Therapeutic bandage contact lenses

Rationale for prescribingA rich history of efficacy …

▪ Celsus -> Honey soaked linen

▪ Ridley -> Glass scleral shell

▪ Kaufman & Gasset -> Hydrophilic lenses

Why hydrogels …

▪ Oxygen permeability

▪ Design flexibility & dimensional stability

▪ Optical clarity

▪ Absorbtion & elution

Therapeutic goals

▪ Pain reduction

▪ Wound protection & surface wetting

▪ Vision

▪ Drug delivery ?


Drug absorbtion and elution

Is drug delivery feasible and practical ?

▪ Lesher & Gunderson. Opt & Vis Sci 70(12) : 1993.

Sustained release rates

Ciprofloxacin -> Etafilcon

Prednisolone phosphate -> Polymacon

Cromolyn Sodium -> Polymacon

▪ Taravella, etal CLAO 24(3):1998.

Assessed AC [Drug] in 21 cataract patients

Group 1: Tobradex q15min x 3

Group 2: Tobradex soaked collagen shield

Anterior chamber levels of drug same for both groups

▪ Would drug impregnated contact lenses work better ?


Drug absorbtion and elution

What is the future for drug delivery bandage lenses ?

▪ Challenges▪ Improve and control drug uptake and release

▪ Impacted by drug ionicity, solubility, molecular size, etc

▪ Impacted by contact lens ionicity, solubility, pore structure, etc

▪ Impacted by patient tear film and blink dynamics

▪ Possible strategies▪ Sandwich (layer) drug within contact lens (Ciolino, Opth 2016)

▪ Alter release kinetics via vitamin E (Shayani, Eye & CL 2017)

▪ Alter release kinetics via fluorous chemistry (Quinn Biomat 2017)

▪ Alter release kinetics and drug duration via nanoparticles (Sharma, J Oc Pharm Ther 2016)

▪ Alter release kinetics by molecularly imprinting contact lenses(White , Opt & Vis Sci 2016)


What are the most common clinical indications?

▪ Bullous keratopathy

▪ Corneal Dystrophies

▪ Corneal abrasion

▪ Persistent & recurrent corneal erosions

▪ Keratoconus

▪ Ocular Surface Disease

▪ Penetrating keratoplasty & DALK

▪ Excimer laser PRK or LASIK

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Bullous keratopathy

▪ Reduces pain

▪ Reduces edema &

improves vision

▪ Adjunct hyperosmotics ?

Pachymetry < 610u.

(Knezovic 2006).

▪ Additional considerations:

DSAEK vs DMEK

Penetrating keratoplasty



Luchs, etal Ophth 104(5):1997

▪ N = 918 Bullous Keratopathy Patients

▪ 4.7% developed ulcerative keratitis

▪ Streptococcus pneumoniae most common

▪ Prophylactic antibiotic conferred no

protective

Risk Factors For Infectious Keratitis?

▪ Steroid use

▪ Bandage lens use Prophylaxis with moxifloxacin

▪ Increased bullae



Clinical case – 56 yom with history of keratoconus and PKP failure

▪ 8 weeks s/p DSAEK OS

▪ Lotemax OS bid

▪ Refit into scleral lens with BCVA = 20/25

▪ OD scheduled for DSAEK

DSAEK vs DMEK?Majmudar OSN 4-25-201497% of 23,000 keratoplasties in 2012 were DSAEKDMEK quicker recovery – 3-4 wks vs several mthsDMEK 95% BCVA > 20/40 vs DSAEK 43% > 20/40DMEK +0.24D shift vs DSAEK +1.1D shiftDMEK 1% rejection rate vs DSAEK 12% rejection rateDMEK downside? Donor harvesting and procedure technique



Corneal dystrophies

▪ Reduces pain

▪ Improves vision

▪ Adjunct surface osmotics ?

▪ Muro Vs FreshKote

when BCL worn daily

▪ Additional considerations:

PTK vs DALK

DSAEK vs DMEK

Penetrating keratoplasty



56 yof with history of Fuch’s Dystrophy

Ocular history: No c/o. ‘vision in right eye a little blurry.’ Wearing soft lenses ou qd x 12+ hours. Clear care qhs. Replace q 1 mth. Muro ung ouqhs.

VA cc OD 20/60 & OS 20/30.

Biomicroscopy – Grade 1 ABMD ou &

grade 3 Fuch’s endothelial dystrophy.

Impression: ABMD ou, Fuch’s corneal

dystrophy ou.

Plan: DMEK consult.



Clinical Case – 48 yof with history of corneal dystrophy

Ocular History: Reis-Buckler’s corneal dystrophy. PTK OD 2006 and OS 2007. c/o intermittent irritation, photophobia, and blurred VA.

Systemic History: Excellent. No medications. NKDA.

Family History: Mother and Daughter with Reis-Buckler’s.

▪ Biofinity Toric 8.6

OD +200-125x40 = 20/25-

OS +050-075x140 = 20/20-

Clear Care qhs

Polysporin ung OU qhs prn

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Corneal abrasion

▪ Reduces pain

▪ Accelerates healing ?

▪ Adjunct prophylactic antibiotics

Donnenfeld, etal Ophth 102(6):1995.

N = 47 Eyes with corneal abrasion randomized to receive

Patch vs Bandage lens vs Bandage lens & nsaid gtt

▪ No significant difference in healing time between treatment groups

▪ Bandage lens groups returned to normal activities more quickly

▪ Significant decreased pain in bandage lens & nsaid group



Persistent epithelial defect / recurrent corneal erosion

▪ Reduces pain

▪ Accelerate

healing ?

▪ Adjunct

prophylactic

antibiotics

▪ Additional considertions:

Is doxycycline, azithromycin, or topical steroids indicated ?

Is stromal puncture, diamond burr debridement, or ptk indicated ?



How successful are more aggressive therapies ?

Reidy JJ, Paulus MP, Gona S Cornea 19(6):2000.

N = 104 Patients with history of recurrent corneal erosion

36% male & 64% female

45% History of trauma

29% History of ABMD

17% History of trauma & ABMD

▪ Conservative tx for 50% patients -> 6% recurrence

▪ Stromal micropuncture in 36% patients -> 40% recurrence

▪ Epithelial debridement in 10% patients -> 18% recurrence

▪ Superficial keratectomy in 4% patients -> 25% recurrence



Ocular surface Disease

▪ Less pain, improved surface

protection, & improved vision

▪ Maximal dry eye management

essential prior to bandage lens

▪ Punctal occlusion critical

▪ Silicone hydrogel vs daily disposable … or scleral lens ?

▪ Do the benefits outweigh the risks ?


What are the most common clinical indications?Penetrating keratoplasty (PKP)

▪ Reduces discomfort

▪ Facilitates epithelial

healing

▪ Adjunct antibiotics

& steroids

Additional considerations:

▪ Length of wear ?

Hoefling-Lima, CLAO 2002

▪ bilateral PKP in Sjogren’s syndrome

▪ bilateral c albicans infection



Dohlman K-Pro synthetic cornea

▪ Reduces discomfort

▪ Mitigates epithelial migration

▪ Adjunct antibiotics & steroids

▪ Vancomycin 20 mg/ml bid

▪ Pred Forte bid

Additional considerations:

▪ For how long is bandage worn ?

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Perioperative Surface Ablation

▪ Reduces pain

▪ Accelerates healing ?

▪ Adjunct NSAID, antibiotic, & steroid gtt.

Oral analgesics prn

▪ Limit wear time till re-epithelialization

Biggest challenges of surface ablation

▪ Epithelial defect -> pain

▪ Perioperative myopia -> slow visual recovery

Mini- PRK (Scott MacRae, MD)

▪ 7 mm vs 8.5 mm = 34% reduction in epithelial defect size

▪ Prescribe bandage lens with -1.00 D Rx = better postoperative VA

▪ Bandage lenses for 1-2 weeks



Dohlman, Boruchoff, & Mobilia. Arch Ophth 90(11) :1973.

Tradtional lens options (n = 273 eyes)

▪ Severe keratitis = 1.4%

▪ Infiltrative keratitis = 4.0%

▪ Neovascularization = 2.9%

▪ Lens spoilage = 6.8%

▪ Lens loss = 12.5%

▪ Lens rejection = 13.7%

Tanner & DePaolis. Clin Eye VIs Care 4(4) : 1992.

Disposable lens options (n = 68 eyes)

▪ Severe keratitis = 3.4%

▪ Contact lens acute red eye = 1.7%

▪ Lens spoilage = 3.4%

▪ Lens loss = 19.0%

▪ Lens rejection = 8.6%


What is the real risk of microbial keratitis (MK)?

Saini, etal Eye & Cont Lens 39(5): 2013.

▪ Retrospective review of 103 applications in 74 patients from 2006-2009

▪ 3 episodes of MK (2.9%) with 2 of the cases (2%) in LSCD

▪ Duration of wear ranged from 21 days (EBMD) to 187 days (PBK)

▪ Prophylactic antibiotic use in epithelial defect, postoperative, and high risk cases

▪ Highest risk for MK?

▪ Patients with epithelial defect and concommitant use of prophylaxis antibiotic gtt and topical steroid gtt


What is the real risk of microbial keratitis (MK)?

Zhu, etal Eye Con Lens Epub 2019.

▪ Retrospective review of 6,385 bandage lens applications 2015-2018

in Zanjieng University Hospital

▪ Mean age 48 yrs and mean bandage lens wear time 20 days

▪ 8 cases of infectious keratitis (0.0013%)

▪ Highest risk for MK?

▪ Patients > 50 yoa

▪ Patients s/p PKP and CCXL

▪ Patients wearing bandage lens > 23 days

▪ Patients non-compliant with prophylactic AB’s and bandage lens replacement



Clinical Case – AS 17 yom

Ocular history: ‘Cat scratch laceration’ 2 weeks

prior. Soflens 38 bandage lens OD. Ciloxan OD qid. No c/o.

VA OD cc 20/100 & OS sc 20/20.

Biomicroscopy – OD bandage lens clean & well positioned. Lids flat, conjunctiva clear, isolated corneal ‘macrovacuoles’ OD, ac with occasional cell, iris normal, lens clear.

Plan:

1. Discontinue bandage lens OD

2. Sutures removed

3. Vigamox OD q2h

Epithelial Implantation Cyst ???


What about amniotic membranes?

Amniotic membrane therapy can

▪ Retain moisture

▪ Decrease inflammation

▪ Promote healing

▪ Improve nerve density

▪ Enhance corneal sensitivity

Cryopreserved

▪ Prokera (BioTissue)

Dehydrated

▪ AmbioDisk (IOP Ophthalmics)

▪ BioDOptix (BioD)

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What about amniotic membranes (AM)?

Kotoman, etal PLoS One 10(5):2015

▪ Fixing AM to stabilizing ring (AmnioClip) did not alter biologic properties

▪ Supportive growth factors expressed up to 7 days

John, etal Ophth 2017

▪ Single application of Prokera in severe DED cohort

▪ Improved DED signs, symptoms, and corneal nerve density & function

McDonald ASCRS Meeting May 2017

▪ Dry Eye Amniotic Membrane Study (DREAMS)

▪ Improved DEWS severity level in 88% of patients in 1 week

Sabater & Perez Curr Opin Ophthal 28(4): 2017

▪ While AM does not have stem cells, it provides short-term support in

LSCD regeneration


What about amniotic membranes (AM)?

Morkin & Hamrah Oc Surf 17:2017

▪ Single application of Prokera in 10 eyes with neuropathic corneal pain

▪ 75% improvement in pain scale within 1 week (persisted after removal)

▪ IVCM demonstrated 37% improvement in corneal nerve density

Cheng & Tseng Cornea 36(11):2017

▪ 4 eyes with HSV keratitis treated with Prokera AM and oral acyclovir

▪ Reduced inflammation, rapid re-epithelialization, and sx relief in 1 week

▪ Patients remained sx free for 3 – 51 months

Vlasov, etal J Ref Surg 42(3):2016

▪ 40 PRK patients receive Acuvue Oasys one eye / Prokera other eye

▪ No difference in healing, symptoms, corneal clarity or visual outcomes


What about scleral lenses?Increased popularity due to

▪ More oxygen permeable materials

▪ More sophisticated design

▪ Better understanding of fitting relationship (OCT)

▪ Expanded applications OSD -> ectasia

▪ Zheng, etal GSLS 2015

▪ N = 126 eyes for meridional elevation changes

▪ If elevation delta > 300u, consider scleral lens

▪ Challenges

▪ Multiple designs = confusion

▪ Dynamic nature of fit

▪ Lenses settle ~ 100u over 8 hours Kauffman, etal Opt & Vis Sci

▪ Clinical limitations … handling, fogging, limbal compromise


What about scleral lenses?

JH 49yom

▪ Open globe trauma with phthisis OS

▪ Scleromalacia OD

▪ Pred forte OD qid and GenTeal OD prn

▪ OD cc 20/150 and OS Prosthesis

BCVA 20/50


Clinical considerationsIs IOP measurement through a bandage contact lens accurate ?

Scibilia, Ehlers, Donshik CLAO 22(4):1996.

▪ 10 normal & 10 abnormal eyes –Tonopen & Goldmann tonometry

▪ Measurements taken without and over Acuvue, B&L O4, & Permalens

▪ Both tonometers accurate over all lenses for all eyes

Allen, RJ, etal ARVO 2004.

▪ 20 normal eyes – Goldmann tonometry

▪ Measurements taken without and with PureVision bandage lens

▪ No difference in IOP’s with or without bandage lens

Spakota, etal Con Lens & Ant Eye 7-30-2014 (epub)

▪ 56 normal eyes – Ocular Response Analyzer (ORA)

▪ Measurements taken without and over bandage contact lenses

▪ 35% of eye IOP’s underestimated by 3+ mm Hg when taken over lens

Therapeutic Bandage Contact Lenses

Questions for consideration

▪ What is the rationale for therapeutic bandage lenses?

▪ What are the most common clinical indications?

▪ What ancillary therapies are necessary?

▪ What does the future hold for drug delivery therapeutic

bandages?

Michael DePaolis, OD, FAAO

[email protected]

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corneal dystrophies & degenerations … symposium...corneal dystrophies ... is stromal puncture,...

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