OIS@AAO Ophthalmology Innovation Summit Chicago 10/25/2018
~ 1100 participants
Summary and Take-home Messages
Year in Review
– 10 novel FDA NDA (new drug application) /BLA (biologic license application)
approvals – examples: vyzulta, rhopressa, verisome by eye point, a mucous
penetration peptide, cenegermin by dome, voretigene (Luxturna (R)).
– 700 individual files in FDA for gene therapy; come of age of gene therapy.
– FDA may have a new ophthalmology division soon.
– There are several phase 2 drugs for dry eye syndrome; Xiidra global sales are rising.
– Pharmacotherapy for refractive errors is one of the most important fields. 2.3 billion people with presbyopia. EV06 Encore/Novartis is being improved for presbyopia.
– Drugs acting in muscarine receptors.
– Progressive myopia drugs are being investigated; atropine-based.
– For AMD topical and intravitreal drugs are being investigated.
– For DME anti-integrin drugs, Tie-2 activator drugs are under way.
– Glaukos and Ivants implants approved. Alcon withdraws its implant.
– IdX-dr approved for diabetic retinopathy.
– NEI increased its funding. Private funding was 718mi for ophthalmology last year.
Research to prevent blindness scientific showcase
– Supports early-stage research; supports early-career research.
– Funded over 350mi for eye research.
– Supports targeting retinal vessels at Kellog eye center; aPKC is a novel protein
kinase that may regulate vessel permeability to induce retinal barrier restoration.
– Supports work on retinoblastoma at Vanderbilt medical center; treating retinoblastoma through blockage of small proteins – molecular targeted therapeutics; injection of intra-arterial or intravitreal melphalan is toxic. Model of retinoblastoma in rabbits.
– Supports University of Rochester – project to imaging blood cells in the living retina.
Uses adaptative optics to view red blood cells.
Company showcase 1 (retina and glaucoma)
– Risuteganib (Luminate (R)) – treatment of oxidative stress-induced DME. Integrins play a key role in oxidative stress. There are 7 drugs acting on integrin; one in ophthalmology Xiidra. Phase 2 clinical programs performed; one phase 3 trial for DME planned; one phase 2 trial for dry AMD planned.
– Aerpio – public company. AKB-9778 drug under way phase 2a and 2b clinical Trial to prevent complications of diabetic retinopathy and nephropathy. Patients experience decrease in intraocular pressure. Drug will be investigated for glaucoma as topical formulation.
– Graybug Vision – Focus on extended duration dosing to treat retinal diseases and glaucoma. Bioabsorbable microparticle delivery to enable sustained drug release. Compose is loaded with sunitinib, GB-102 PLGA/10% sunitinib microparticles applied intravitreal. Currently is on phase 1 trial – Adagio study.
– Hemera Sciences – AAV2 gene therapy called HMR59. Transgene product in soluble form of CD59 as intravitreal injection which blocks complement at MAC. MAC is identified in drusen and elevated in human eyes with AMD.
– AGTC – genetic therapies. Large pipeline with multiple partners on various diseases like achromatopsia (A3 and B3 genes), x-linked retinoschisis, x-linked retinitis pigmentosa. Collaboration with bionic sight.
– Lumithera – target dry age-related macular degeneration. Novel use of photobiomodulation against dry AMD. Valeda is the name of the device.
– Gemini therapeutics – product engine company. Focus on precision medicine for dry AMD. Determines dry AMD in specific genotypes. In CFH-AMD patients have genetic variants. GEM103 novel full-length rCFH candidate for intravitreal administration. Study is in preclinical phase development.
– TMi – Translatum Medicus. TMi-018 for late dry AMD in phase 1/2 clinical trial Neurotech pharmaceuticals – encapsulated cell therapy. Intraocular implant that contains genetically engineered cells designed to release therapeutic proteins in a controlled continuous delivery to the retina. Renexus releases CNTF for MacTel is in phase 3 to check ellipsoid zone; and for glaucoma a study is currently in phase 2.
– Eyedaptic – software company: focus on stimulation of augmented reality. Wearable augmented reality vision assistance for AMD patients.
Company showcase 2 (ocular surface diseases)
– Trefoil therapeutics – focus on therapeutics of corneal diseases. For corneal endothelial dystrophy, the current therapy is surgical transplantation of corneal cells; therapy of company aims to regenerate corneal tissue. TTHX1114 may stimulate proliferation in dystrophic human corneas.
– Kala pharmaceuticals focus on dry eye disease. Proprietary mucus-penetrating particle (MPP) technology. Inveltys – post-surgical steroid approved as BID dosing. MPP technology to create nanosuspensions of loteprednol etabonate, or LE, a corticosteroid designed for ocular applications, two product candidates.
– Novaliq – water-free drug delivery technology. EyeSol. Two studies, cyclasol and novo3.
– Oyster Point Pharma – focus dry eye disease. Acts on trigeminal parasympathetic pathway on receptors, two drugs applied intranasal under phase 2 trials.
– Mc2 therapeutics – new class of vehicle offering a number of unique advantages in the development of new topical drugs.
– Silktech – focuses on innovating and developing silk-derived protein (SDP) products for ocular surface disease. SDP-4 eye drop product profile in initial phase of phase 2 trial.
– Sight Sciences. OMNI Surgical System a manually operated device for the delivery of small amounts of viscoelastic fluid, for example HealonTM or HealonGVTM during ophthalmic surgery. It is also indicated for the cutting of trabecular meshwork when a trabeculotomy. TearCare® System available in 2019, a software controlled, wearable eyelid technology that provides thermal energy to meibomian glands.
– Panoptes pharma – new molecule PP-001. Focus on uveitis, retina and dry eye disease. PP-001 is a specific nanomolar inhibitor of an essential enzyme of de novo pyrimidine pathway leading to inhibition of expression of pro-inflammatory IFN-γ and IL-17. Only 2-4 injections per year against uveitis, no increase in intraocular pressure.
– Eyevensys – therapy of non-infectious uveitis. EYS606 granted an Orphan designation. EyeCET treatment procedure, which takes less than 5 minutes, is designed to provide the patient with a local and safe treatment with long lasting effects, between 3 and up to potentially 12 months.
– iSTAR medical – MIGS anti-fibrotic medical grade silicone STAR material
– Mati Therapeutics – phase 2 trials. Punctal Plug Drug Delivery System. PPDS compatible with different types of molecules. Two formulations into clinical trials – latanoprost for glaucoma and olopatadine for allergy relief.
Company showcase 3 (Miscellaneous)
– Aura – AU-011. Causes acute tumor cellular necrosis upon light activation against choroidal melanoma. Orphan and fast track designation, phase 1b/2 study under way. Very good for tumors near optic nerve.
– Presbyopia therapies – topical biotic mechanism of action. Works different mechanism, depth of angle. Drug aceclidine + tropicamide. 3 line improvement monocular vision outcome achieved. Safety phase 2b results.
– Arcscan – ultrasound evolved.
– Eyenovia – products in various fields. MicroPine microdose formulation of atropine for the prevention of progressive myopia (nearsightedness) in children. MicroStat first-in-class fixed combination microdose formulation of phenylephrine and tropicamide for mydriasis during eye examination. MicroProst prostaglandin microdose formulation for treatment of glaucoma. MicroTears microdrop ocular surface tear replenishment.
– Powervision – fluidvision lens. Accommodating Intraocular Lens.
– Zepto – pulse capsulotomy device. does capsulotomy, hidrodissection. FDA clearance in 2017. May stop posterior capsule opacification.
– Neurolens – new spectacle lens category the contoured prism to bring eyes into alignment. https://www.neurolenses.com/about-us/
– ReNeuron – stem cell technologies to treat retinitis pigmentosa and cone Rod dystrophy.
Rise of AI and analytics in Ophthalmology
– Dimitri Azar: ophthalmology is behind in artificial intelligence. AI used in diagnostic imaging. Most AI nowadays is in diagnostic imaging. Various applications in ophthalmology, retina diseases most relevant. Dry eye getting complex and is a good opportunity. DEWS2 a rigorous approach, AI may simplify.
– Philips is partning with Alcon.
– Santen is interested in new ideas.
– Tracery ophthalmics – clinical stage ophthalmic imaging & health data analytics company specializing in precision medicine and customized clinical trial design, focusing on AMD -OphthoRobotics – technology assisted intravitreal injections
– Aerie pharmaceuticals – Rhopressa for and Rocklatan for glaucoma.
– Oxurion – mab anti-PlGF, plasma-kallikrein inhibitors, powerful integrin pan-RGD drug. Three drugs in clinical trials for DME.
– EyePoint – Dexyxu 517microgram dexamethasone biodegradable implant to prevent post-cataract surgery inflammation; lasts 24-48 hours, effect lasts up to 3weeks.
– Opthea – novel biologic therapy, OPT-302, blocks VEGF-C and VEGF-D. Completed a Phase 1/2a clinical trial in the US investigating OPT-302 in wet AMD patients. Currently enrolling Phase 2 clinical trial for patients with wet AMD and DME.
– Clearside – suprachoroidal corticosteroid triamcinolone acetonide for non-infectious uveitis.
AAO Meeting – Subspecialty Day
Diabetic retinopathy (John Wells, USA)
DRCR.net have changed diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) treatment.
– Protocol I: Center involved DME
– Ranibizumab 0,5mg with prompt or deferred laser
– Triamcinolone 4mg with prompt laser
– Prompt laser with sham injection
– Protocol T: Center involved DME
– Aflibercept 2mg vs. Ranibizumab 0,3mg vs. Bevacizumab 1,25mg- Protocol S: PDR with center involved DME
– Ranibizumab 0,5mg vs. panretinal photocoagulation (+Ranibizumab if DME)
– Protocol U: Persistent DME after anti-VEGF
– Ranibizumab 0,3mg vs. Dexametasona + Ranibizumab
– Anti-VEGF therapy is now the mainstay of treatment of DME.
– DRCR protocols have clarified many issues:
– Laser should be deferred for 6 months.
– Treatment burden declines over time.
– Aflibercept is more effective in eyes with VA 20/50.
– All 3 agents equally effective in eyes with VA 20/32 – 20/40.
– Bevacizumab reduces OCT edema less effectively.
– Adding steroids for persistent DME is not beneficial.
– Eyes with PDR and DME did better with ranibizumab alone vs. ranibizumab plus PRP through 2 years but not 5.
– Visual acuity response at 12 weeks following 3 monthly injections was associated with 2-year outcomes.
– Regardless of anti-VEGF agent used (AFL, RBZ, BEV).
– However, a suboptimal response (<5-letter gain) after 3 injections did not preclude further meaningful vision improvement (i.e., 2-line gain) without switching therapy.
– About 2/3 of the variation in 2-year outcomes remains unexplained.
– Same % of eyes end up 20/40 or better (e.g., about 85% with aflibercept) whether <5-letter or ≥ gain after 3 injections.
– Little evidence to suggest switching frome the DRCR.net anti-VEGF treatment
regimen for DME after 3 or 5 injections will result in better vision results (e.g.
Protocol U) than continuing the DRCR.net treatment regimen.
– Further studies needed comaring DRCR.net anti-VEGF treatment regimen for DME
with alternative regimens.
– Brolucizumab: smaller size may allow longer dosing interval
– The drug is significantly smaller than other anti-VEGF agents. – Bevacizumab is about 150 kilodaltons (KD), aflibercept is about 100 KD, and ranibizumab is about 50 KD whereas brolucizumab is about 25 KD.
– Compared to the 0,5mg ranibizumab dose, a 6,0mg dose of brolucizumab represents 22x more molar concentration.
– What kind of drug is Pembrolizumab?
– PD-1 and PD-L1 inhibitors: – Pembrolizumab, Nivolumab, Avelumab, Duralumab.
– CTLA-4 inhibitor: Ipilimumab.
Brolucizumab for neovascular AMD: the 2 year HAWK and HARRIER results (Pravin Dugel, USA)
– Phase 3, randomised, double-masked, multicenter trials of brolucizumab vs. aflibercept for neovascular AMD: ninety-six-week results from HAWK and Harrier Studies.
– Visual acuity achieved by brolucizumab at week 48 was maintained at week 96.
Successful completion of q12w interval by brolucizumab at week 48 was highly predictive of continuing on a q12w interval.
– The superior anatomic results seen for brolucizumab at weeks 16 and 48 were maintained at week 96.
– The overall safety profile of brolucizumab was comparable of aflibercept.
Nanoretina (Marco Zarbin, USA)
– Nanotechnology: involves the creation & use of materials & devices < 100 nm in size.
– Ophthalmic nanoscale technology: rationale
– Alternative to retinal prosthesis for ganglion, bipolar, or residual cone cell stimulation.
– Potential advantages of nanoscale technology: higher spatial resolution and minimally invasive surgery (intravitreal/subretinal injection for delivery vs. major surgical procedure to implant retinal prosthesis.
– Nanotechonology: Optogenetics
– Mechanism: Neurons express exogenous light sensitive molecules linked to ion channels.
– Delivery: Intravitreal or subretinal injection
– Nanotechnology: Photoswitch
– Mechanism: Activate endogenous ion channels with molecules that change shape when illuminated.
– Delivery: Intravitreal injection
– Nanotechnology: Quantum Dot
– Mechanism: Activate endogenous ion channels by changing membrane potential across cell membrane (dipole or Faradaic current).
– Delivery: Intravitreal injection
Gene therapy for wet AMD (Szilard Kiss, USA)
– Gene therapy for wet AMD offers promise.
– Early studies established the potential for safe delivery.
– Anti-VEGF portein levels will need to be high enough to impact anti-VEGF need.
– Gene therapies with anti-VEGF proteins similar to ranibizumab and aflibercept may have more potential.
– Automatization and standardization will enable safer and more reliable subretinal
Treatment of hypotonic after surgery for PVR (Tarek Hassan, USA)
– Eyes with attached retinas after PVR repair can develop intractable hypotony for a number of reasons: ciliary body abnormalities (PVR (particularly anterior), ischemia, inflammation, trauma, cyclodialysis cleft), choroidal detachment, surgical or traumatic filtering bleb, uveoscleral outflow abnormalities.
– Large retinectomies during PVR repair expose more bare RPE, choroid, sclera: increase aqueous flow through the sclera. More likely with larger retinectomies; less likely in eyes with silicone oil.
– Temporary and unsustainable attempts at Rx for post-PVR repair hypotony: viscoelastic in anterior chamber, viscoelastic in the vitreous cavity, repeat fluid-gas exchanges, silicone oil placement, ibopamine (sympathomimetic D1 (dopamine) receptor agonist.
– End-stage persistent hypotony can be treated by topical difluprednate (Durezol (R); reported 6x as powerful prednisolone) QID. Well tolerated.
– All eyes had large retinectomies.
– Increase IOP gradually over several months.
– No difference based on phakic or silicone oil status.
– Side effect: increase IOP can be dramatic.
– Eyes not previously steroid responsive (to topical prednisolone, intravitreal triamcinolone, and intravitreal dexamethasone).
Butterfly sutures for temporary closure of sclerotomies (Claus Eckardt, Germany)
– Literature review
– Arana, Moreira, Grandinetti, et al. Novel releasable suture technique… Retina, in press: 7-0 Vicryl, 5 days.
– Song, Shin, Lee. Adjunctive use of a novel releasable suture technique… Retina 2011: 8-0 nylon 1 day.
– Lee, Song. Releasable suture technique… Retina 2008: 8-0 nylon, 1 day.
– Cases that may need suturing: high miopia, prior vitrectomies, young age, prolonged
surgical time, silicone oil tamponade (suture removal after 4-5 days!)
– Surgical technique: perform a double removable slit-knot; suture removal at day 1 postop (appears to be safe). Suture removal is quick and easy.
– Releasable butterfly sutures save conjunctiva and sclera.
Avoidable problems leading to redetachment (Steven Charles, USA)
– Failure modes
– Surgical: untreated retinal breaks/holes/tears.
– Biological: PVR (after appropriate surgery, iatrogenic (excessive retinopexy (especially cryo), operating on inflamed eyes.
– Poor visualization common cause of both untreated retinal breaks and residual traction.
– Tradeoff: combined phaco can result in miosis which may require iris hooks, iris hooks may increase inflammation, inflammation contributes to PVR.
– Posterior synechia, IOL tilt & decentration, and poor refractive outcomes occur with combined Phaco-Vit for RD.
– Posterior Capsular opacification
– Tradeoff: intraoperative capsulectomy results in IOL fogging after fluid-air exchange with all IOL materials not just silicone; never remove central anterior vitreous if prior YAG capsulectomy.
– Use wide-angle visualization and/or scleral depression to ensure visualization of peripheral retina.
– Conceptualization is key aspect of visualization
– Patient’s evolving “shadow” history may help locate initial retinal detachment and break(s).
– Highest point of detachment may help find breaks (Lincoff rules).
– Concentric demarcation lines may point to retinal break(s).
– Localized pigmentation often indicates break location because of RPE apical process elongation and melanin migration (adaptive surface area increases to absorb SRF).
– Ends of lattice degeneration common break location.
– Use core vitrectomy as a diagnostic tool
– Subretinal fluid (optical effect known as Schilieren) may stream from break(s) during peripheral vitreous removal.
– Vitreous collagen fiber radial orientation may help locate flap tears.
– Confluent laser to “suspicious” areas after internal drainage of SRF combined with fluid-air exchange often helps find break(s).
– Visualization of residual vitreous traction “under” air or PFCL
– Residual vitreous traction can easily be visualized using specular reflection/sheen and refractive effects at vitreous-air interface during trans-hole or retinotomy drainage of subretinal fluid combined with fluid-air exchange (or PFCL). – Localized elevation of equatorial retina indicates residual vitreous traction. – Manage using vitrectomy “under” air (or “over” PFCL).
– Combining scleral buckling with PPV is not the answer
– No acceptable randomized clinical trial evidence that combining a buckle with vitrectomy increases success rates compared to PPV alone.
– New breaks and PVR often occur posterior to encircling elements; even broad buckles.
– Buckle complications: induced axial myopia (unhappy patient if prior refractive surgery), diplopia, longer operating times, increased labor cost, more general anesthesia use, pain, ocular surface disorder from non-aligned conjunctival closure, slight ptosis from levator aponeurosis damage due to superior rectus traction suture, conjunctiva, Tenon’s, and episcleral scarring problematic if subsequent glaucoma surgery is required, buckle extrusion or intrusion.
– Rows of 360o laser is not the answer
– Increased inflammation; possible increased PVR.
– Increased risk of lens bump
– Toroidal (donut) detachment between equatorial or post-equatorial rows of laser and ora serrata. – Increased PVR. – Anterior segment neovascularization due to VEGF produced by chronically elevated anterior retina.
– Breaks missed at surgery and/or new breaks often occur between laser spots or posterior to laser spots.
Pearls for large macular holes (MH) (Carl Claes, Belgium)
– Objectives of MH surgery: approximate the borders of the MH, ASAP after/during surgery, glial proliferation from Müller cells worsens visual prognosis, homogenous reflectivity from ELM/EZ.
– Main indications of retinal relocation: myopic MH, failed MH surgery, 750-1500 microns MH.
– Surgical technique of retinal relocation: vitrectomy + ILM peeling, decaline covers the hole, retinal detachment posterior pole, air-fluid exchange, 1000 Cs silicone oil + micro-endodrainage.
– Summary: retinal relocation seems viable alternative for large, myopic, recurrent MH repair with limited complications.
A new way to close holes and breaks (Stanislao Rizzo, Italy)
– Novel biocompatible film based on amniotic membrane.
– Amniotic membrane plug is placed in MH’s subretinal space.
– No gas tamponade, only air.
– Short prone position.
– Used to close peripheral and macular holes (even in high myopic MH).
– Author reported good anatomical outcomes.
– Conclusions: for the first time, interruption of the retinal tissue has been resolved with a regenerative process, not with a destructive action. Unlike other surgical procedures, anatomic and functional results were very encouraging. The technique is safe and very simple for everyone.
Hypersonic vitrectomy: continued clinical experience and technical improvements (Carl Awh, USA)
– Hypersonic vitrectomy: a method of vitreous removal in which ultasonic power is used to actuate the vitrectomy probe.
– Guillotine vitrector: 5000 cuts/minute; hypersonic vitrector: 28 kHz (1.7 million “cuts”/minute.
– Hypersonic liquefaction: occurs at the outer margins of the port; no “cutting” by other portions of the tip; different por geometries and locations are possible.
– The small port is very close to the tip of the vitreoctome.
– Hypersonic vitrector: flow is dependent upon a new variable: stroke (0-60 microns) (instead of cute rate), besides vaccuum (less vacuum than the standard method) and infusion pressure.
– Indications: vitreous opacities, macular hole, macular epiretinal membrane, rhegmatogenous retinal detachment, retained lens material, vitreomacular traction, vitreous hemorrhage, diabetic traction retinal detachment, retained silicone oil.
– Encouraging early experience: able to successfully and safely address typical vitreoretinal pathology, may have advantages in selected cases, continued development in progress (port and handpiece modified; 25ga and 27ga probe developed).
Development of a deep learning system for digitally enhanced internal limiting membrane (Kazuaki Kadonosono, Japan)
– Automated artificial intelligence method to analyse images of the macular region, after chemical staining of the eye.
– ILM is currently able to digitally enhanced using 3-D systems.
– Deep learning machines have demonstrated high sensitivity in detecting the ILM, showing the possibility in facilitating ILM peeling.
Final visual acuity, not amount of improvement, must be the measure of our success in epiretinal membrane (ERM) surgery (Colin McCannel, USA)
– Historical indications for ERM peeling surgery: BCVA 20/70 or worse, severe metamorphopsia.
– Typical improvement folowing ERM peel: 2 lines of visual acuity, modest improvement in metamorphopsia.
– Historical surgical indications will leave patients with suboptimal visual acuity, unsatisfactory vision function.
– ERM surgery: retina surgeons must strive for best visual acuity in management of disease.
– ERM surgery: goal of ophthalmic intervention must be excellent final visual acuity and function: visual acuity of 20/20-20/25, minimal metamorphopsia. To achieve these results, earlier intervention is required.
– Risks of vitrectomy compared to cataract surgery: retinal detachment (1-2% X 1.8% (long term) with cataract sg), endophthalmitis (1/2000 X 1/1000 (cataract sg)).
Vitrectomy for diabetic macular edema (DME): why, how and when (Gaurav Shah, USA)
– Rationale: Why
– Elimination of clinical and subclinical tractions, not visible with conventional means.
– Removal of a pathological vitreous, full of inflammatory mediators, which favor the persistence of edema.
– Increased oxygenation of the inner layers of the retina that favor arteriolar vasoconstriction.
– Vitrectomy for Diabetic Edema Study (DRCR.net): Protocol D.
– Possibly only failed DME cases underwent vitrectomy (those which already had permanent damage to the outer retina).
– DME visual recovery: SD-OCT was not yet available.
– Too late.
– Best candidates: OCT surrogate markers (when), OCT morphology (who).
– Prognostic factors
– ELM integrity correlates with initial VA.
– ELM and IS/OS integrity best predictor of response to vitrectomy.
– Disruption of ELM may appear as hyperreflective dots and be negative predictive factor (extravasated lipoproteins or lipid-laden macrophages migration into the outer retinal layers damages the photoreceptor cells and disrupts the ELM).
– Resolved edema and disorganization of the retinal inner layers (DRIL): association with logMAR VA after resolution of edema.
– Difference in size of foveal avascular zone (FAZ): 0.1mm increase in the size of the FAZ is associated with a 37.7% increased risk (odds ratio = 1.377) of no reduction in macular edema after vitrectomy.
– Parallelism (how straight the retinal layers are) may be calculated. Loss of parallelism may be due to alterations in ellipsoid lines, ELM lines, hyperreflective foci irregular RPE lines.
– OCT morphology (who)
– DME displays 4 different patterns.
– Diffuse retinal thickening with: – Sponge-like diffuse retinal thickening (SDRT) (35%). – Cystoid macular edema (CME) (24%). – Serous retinal detachment (SRD (16%). – All three fingings (FULL) (25%).
– Triamcinolone: CME > SDRT > FULL > SRD
– IVB: SDRT > FULL CME >> SRD
– Vitrectomy: SRD > FULL > CME > SDRT
– Why: multitude reasons.
– How: peel the ILM.
– When/Who: OCT surrogate markers.
Myopic foveoschisis (Ramin Tadayoni, France)
– 10-30% highly myopic eyes (> 6D/ >= 27mm axial length) when the staphyloma involving the fovea.
– Many patients are asymptomatic. Various degrees of visual loss. Metamorphopsia or scotoma are uncommon (unless macular hole).
– OCT is the best imaging for diagnosis (thickening of the fovea, stretched with non-reflective spaces, in particular Henle fiber layer (column-like), vitreous often attached (>85%), +/- membrane, complications (macular hole, detachment…).
– The anatomy-function correlation is weak and poorly understood (don’t forget to consider differential diagnosis).
– Surgery benefits from modern technics and technologies (we see better, we do better, and safer than before).
– The main factor influencing the postoperative BCVA is the preoperative BCVA.
Retinal malpractice: the 30 year OMIC experience (George Williams, USA)
– OMIC: founded by AAO in 1987 as an independent risk retention group for medical liability. Now insures over 5000 ophthalmologists in all 50 states making OMIC the largest insurer of ophthalmologists in the country.
– ROP lawsuits are rare but high severe (# and amount of payments).
– Post discharge: can’t rely on parents.
– Asking parents to schedule initial outpatient exams puts baby at risk.
– May not bring baby for office exams: office mst have robust appointment tracking system; office must know how to contact Child Protective Services.
– Intravitreal injections (IVI): low frequency and low severity (# and amount of
– More common with bevacizumab and steroid.
– Intravitreal injection issues – Carefully explain all treatment options and document the reasons for the chosen therapy. – Explain the expected visual outcome and the expected duration of treatment. – Advise of off-label use and provide informed consent. – Use aseptic technique. – Monitor IOP and optic nerve.
– Avastin silicone floaters lawsuit: patients who receive injections of Avastin may develop silicone “floaters”or “air bubbles”as a resulto f silicone oil that was left in their eyes from the syringe.
– Wrong events with intravitreal injections: cases of wrong gas concentration, drug, eye, dose.
– Time out: before incision
– Critical event: gas dilution.
– Team advised that gas needs to be diluted and why.
– Nurse and surgeon agree on gas concentration.
– Nurse repeats gas concentration back to MD.
– MD watches and confirms process durring dilution.
– Consequences of “wrong” events
– Patient harm
– Deemed below standard of care by defense and plaintiff experts.
– MD almost always liable since has most knowledge.
– Report to National Practitioner Data Bank if payment.
– Mandatory reports to medical board in some states (even if no harm or claim).
– Review by Joint Commission or state.
– Resources available to all at www.omic.com
– Ophthalmic-specific surgical checklist
– Time out protocol for intravitreal injections.
– Sample consent.
Micropulse (MSP) laser vs. Photodynamic therapy (PDT) for central serous chorioretinopathy (CSCR) (Jay Chhablani, India)
– MSP laser seems to be at least as effective or potentially superior to PDT in the treatment of chronic CSCR.
– PDT is effective. However, it bears the risk of side effects (p.e., choroidal neovascularization), and is an invasive procedure.
– Both conventional MSP lasers and Navilas are laser equivalent.
– Navilas allows use without contact lens, definitely improving patient comfort and cooperation.
Imaging of neurovascular unit (Richard Spaide, USA)
– The combination of neuronal cells, glial cells and layers of blood vessels is called neurovascular unit.
– Neurovascular unit: blood-retina barrier, regulation of blood flow, inflammatory processes, processing and transmission of data.
– Diseases affect inter-relationships among components.
– Ganglion cell layer: ganglion cell bodies, astrocytes, Müller cells; supplied by superficial plexus.
– Retinal nerve fiber layer: nerve fibers, astrocytes, Müller cells; supplied by the radial peripapillary capillary network.
– Glaucoma and diabetes have thin GCL and both have decreased vascular density in macula.
– Glaucoma has decreased nerve fiber layer.
Swept-source OCT and OCT angiography for pathologic myopia (Kyoko Ohno-Matsui, Japan)
– In a long-term, myopic CNV develops macular atrophy.
– Myopic CNV maintains blood flow within the area of macular atrophy: scleral feeder vessels from short posterior ciliary arteries. Communication may occur between CNV and scleral vessels through Bruch’s membrane defects.
– Ultra-widefield swept-source OCT can provide tomographic images of various tissues from the vitreous to the sclera with high resolution and extended size.
– Valuable method to identify how vitreous and sclera become pathological, and how such pathologies can lead to vitreoretinal tractional diseases in synchronicity.