No. of Meds ELT: Excimer Laser Trabeculostomy Clinical Update, 2009 Michael S. Berlin, MD, MS...

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0 1 2 3 Pre-op 6m 1y 2y 3y No. of Meds ELT: Excimer Laser Trabeculostomy Clinical Update, 2009 Michael S. Berlin, MD, MS Glaucoma Institute of Beverly Hills, Jules Stein Eye Institute, UCLA Prof. Ulrich Giers; Detmold, Germany Dr. Lea Kleineberg; Detmold, Germany Kevin Taliaferro, B.A., Glaucoma Institute of Beverly Hills Post-Op Single site coaxial Swan Jacob Osher Dual site 1. Gonio Lenses 2. Endoscopes Conclusions Procedure A fiberoptic probe is introduced through a paracentesis to contact the trabecular meshwork & deliver non-thermal 308nm XeCl excimer laser energy to excise the trabecular meshwork, juxtacanalicular trabecular meshwork, and the inner wall of Schlemm’s canal without damaging the outer wall or the collector channels. Prof.D r.E.Lütjen-D recoll,Erlangen No thermal damage to the TM Results Instrumentation 1.) XeCl-Excimer Laser 308 nm wavelength 1,2 mJ Application Energy 80 ns Pulse Length 20 Hz Repetition Rate 2.) Fiber-Optic Delivery System : 3. Viewing the Meshwork Spot size : 200 µm Application Energy : 1,2 mJ (~ 38 mJ/mm2) Tip Bevel : 65° Fiber Length : 2 m Tuilaser AIDA Tuilaser AIDA Prof. Jens Funk Prof. Ulrich Giers Prof. Potzche Osher Lens Swan Jacob Lens Coaxial Endoscope References © Eyelight, Inc. 2009 Technical patents are issued and pending. ELT is not yet available in the U.S. 0 5 10 15 20 25 30 35 P re- op 1 d 1m 3m 6m 1y 2y 3y IO P (m m Hg) ELT in Phakic Eyes 33 patients / 3 years Giers, Kleineberg, 2009 Patent openings verified by ind blood reflux from Schlemm’ Canal 3 years after EL Patent openings into Schlemm’s Canal intact 2.5 years after ELT Pt # Age IOP Pre-op IOP 1 day IOP 1 month IOP 3 month IOP 6 month IOP 1 year IOP 2 year IOP 3 years 1 52 29 14 19 17 17 18 16 18 2 53 25 13 17 14 14 18 17 17 3 62 36 15 19 19 21 32 18 24 4 53 39 12 16 19 16 22 22 21 5 61 15 10 16 17 17 12 13 - 6 26 27 15 18 18 18 25 16 18 7 63 20 13 14 15 16 17 15 13 8 27 29 15 19 19 24 17 18 19 9 34 23 14 16 19 12 19 18 16 10 29 27 12 12 13 14 12 16 17 11 64 28 12 16 19 19 24 15 20 12 44 26 14 16 16 17 17 18 20 13 82 33 12 15 17 18 18 18 16 14 76 18 13 14 12 17 14 15 14 15 60 24 11 14 14 16 15 15 14 16 53 14 10 14 11 10 10 10 11 17 69 20 13 17 13 18 17 19 10 18 44 36 19 20 22 26 22 19 - 19 76 18 10 11 11 12 12 14 11 20 70 22 12 13 16 19 15 16 10 21 79 22 8 11 12 12 11 11 13 22 60 22 12 13 15 13 17 18 12 23 62 26 11 16 16 13 17 18 17 24 44 23 12 15 15 19 16 15 21 25 29 23 11 14 16 15 17 16 17 26 63 17 11 12 13 16 15 16 13 27 62 24 15 16 18 20 18 19 18 28 71 30 12 16 16 19 20 17 16 29 48 25 7 19 14 12 16 19 16 30 48 29 9 15 13 13 15 20 19 31 45 39 13 18 20 23 23 16 18 32 62 25 11 15 16 18 17 17 - Introduction ELT (Excimer Laser Trabeculostomy) is a minimally invasive, outpatient surgical procedure which corrects the anatomical pathology responsible for most open-angle glaucoma: outflow obstruction at the juxtacanalicular trabecular meshwork and the inner wall of Schlemm’s canal. ELT uses a 308 nm XeCl excimer laser to ablate the trabecular meshwork, increasing outflow within the eye by using Schlemm’s canal as the conduit, resulting in a significant and enduring decrease in IOP. ELT does not create a filtering fistula or bleb and the conjunctiva remains intact. ELT enables Pneumatic Canaloplasty . Non-thermal ablation turns tissue into gas, which validates continuity of flow between ablation sites, presumably via Schlemm’s canal. The gas is also anticipated to dilate Schlemm’s canal and collector channels, improving aqueous outflow. U. Giers U. Giers Pneumatic Pneumatic Canaloplasty Canaloplasty 36% IOP reduction 91% Meds reduction 0 0.5 1 1.5 No. of Meds P re-op 6 M o 2 Y r. 3 Y r. ELT combined with Phaco surgery 33 patients / 3 years Giers, Kleineberg, 2009 39% IOP reduction 70% Meds reduction 0 5 10 15 20 25 30 Pre-op 1 D ay 1 M o. 3 M o. 6 M o. 1 Yr. 2 Yr. 3 Yr. IOP (mm Hg) 0 5 10 15 20 25 30 35 pre op 1 d 1m 3m 6m 1y 2y 3y IOP (mm Hg) 0 0.5 1 1.5 2 2.5 3 N o.ofM eds pre op 6m 1y 2y 3y 47% IOP reduction 77% Meds reduction ELT in Pseudophakic Eyes 15 patients / 3 years Giers, Kleineberg, 2009 PT# Age IOP pre-op IOP 1 day IOP 1 month IOP 3 months IOP 6 months IOP 1 year IOP 2 years IOP 3 years 1 86 25 14 21 18 17 16 - 2 76 22 16 13 16 14 12 13 11 3 51 38 20 31 19 18 18 23 20 4 66 22 18 33 11 11 12 11 10 5 83 23 17 18 17 16 14 17 16 6 83 21 13 18 14 18 12 14 10 7 89 16 10 16 18 14 15 16 12 8 68 37 17 25 20 23 19 16 19 9 83 28 16 10 11 11 10 11 11 10 78 29 37 18 20 16 13 12 11 78 26 12 17 18 16 20 14 14 12 83 36 8 16 14 18 12 12 18 13 90 20 10 12 15 15 - - - 14 72 26 15 14 15 12 12 14 - 15 90 32 13 14 16 15 17 11 - PT# Age IOP Pre-op IOP 1 day IOP 1 month IOP 3 months IOP 6 months IOP 1 year IOP 2 year IOP 3 year 1 78 17 14 11 11 13 12 12 13 2 79 20 23 14 11 11 11 10 11 3 82 27 28 11 11 12 10 14 14 4 73 27 12 11 12 11 12 14 13 5 78 26 18 13 12 17 14 16 14 6 81 21 14 13 14 18 16 15 13 7 69 19 14 13 11 11 11 11 - 8 78 28 14 13 18 16 14 15 14 9 79 18 8 11 11 13 12 12 11 10 77 23 17 9 9 10 9 10 10 11 76 27 17 18 14 17 15 13 14 12 72 22 14 11 12 11 11 12 14 13 73 20 13 13 11 11 12 16 15 14 64 20 15 16 11 16 12 12 14 15 78 20 12 16 12 14 16 15 14 16 78 15 13 11 11 13 12 12 Fistul. OP 07/06 17 72 17 11 14 13 14 14 14 12 18 71 21 19 16 18 16 15 13 14 19 82 26 17 14 14 17 16 16 15 20 66 26 26 16 13 18 20 16 14 21 73 18 13 12 14 12 12 14 11 22 68 30 30 13 13 16 12 11 - 23 71 18 24 18 14 13 18 13 - 24 80 18 10 11 11 10 11 11 - 25 81 18 10 10 10 11 9 10 - 26 67 10 11 10 10 10 8 4 - 27 78 24 10 19 13 12 11 - - 28 77 17 12 12 12 12 11 11 - 29 83 23 16 17 15 16 16 20 - 30 82 19 11 10 11 12 10 11 - 31 71 19 10 13 16 14 16 11 - 32 71 18 20 11 11 11 11 14 - 33 78 22 9 12 11 16 10 11 - • Babighian S, Rapizzi E, Galan A; Efficacy and Safety of ab interno Excimer Laser Trabeculotomy in Primary Open-Angle Glaucoma: Two years of Follow-up; Ophthalmologica. 2006;220(5):285-90 • Berlin, M.S. ELT, Excimer Laser Trabeculostomy Ocular Surgery News Vol. 19, no. 3, Feb 1, 2001 pp. 48-49 • Berlin, M.S., Ahn, R. Perspectives on new laser techniques in managing glaucoma. Ophthalmology Clinics of North America, 8(2): 341-363, 1995 • Berlin M: We need a trabecular meshwork procedure that works. American Glaucoma Society Annual Meeting, San Jose (2002) • Berlin M, Funk J, Georgaras S, Giers U, Montrone F, Specht H, Welt R: ELT User Meeting, ESCRS Munich 2003 • Berlin M: ELT Excimer Laser Trabeculostomy: Update 2003 ASCRS (2003) • Berlin M, Funk J, Pache M, Wilmsmeyer S, Giers U, Kleineberg L, Ahmed I: Excimer Laser Trabeculostomy: A new, minimally invasive surgical procedure for the treatment of open- angle glaucoma, Glaucoma Today (2004) • Berlin M, Taliaferro K: Excimer Laser Trabeculostomy: Normalizing IOP and Restoring Physiologic Outflow in Glaucoma, Glaucoma Today (2009) • Funk J: Phako + ELT, DGII Ludwigshafen (2003) • Funk J, Schlunck: Endoskopisch kontrolliert Er:YAG-Laser Gonoiotomie. Ophthalmologe. Jan;95(1):33-6 (1998) • Grant WM. Experimental aqueous perfusion in enucleated human eyes. Archives of Ophthalmology 1963;69:783-801. • Kaufmann R, Hibst R: Pulsed Er:YAG and 308nm UV excimer laser: an in vitro and in vivo study of skin-ablative effects. Laser Surg. Med. 9 (2) 132-140 (1989) • Krasnov MM: Laseropuncture of anterior chamber angle in glaucoma.AmJOphthalmology 75:674-678 (1973) • Montrone F, Pellicani L, Rana G, Pesce P: ELT RAZIONALE E METODICA ENDOSCOPICA, Glaucoma Up To Date, Bari (2003) •Neuhann Th, Scharrer A, Haefliger E: Excimer laser trabecular ablation ab interno (ELT) in the treatment of open- angle glaucoma, Ophthalmo-Chirurgie 13:53-58 (2001) • Neuhann Th, Scharrer A, Haefliger E: Laser ablation used to treat chronic open-angle glaucoma in pilot study, Ocular Surgery News Vol. 12, No. 11 (2001) •Schrems W: Excimer Laser Trabekelablation ab interno, DOC Nürnberg (2002) •Sourdille P: Study ab interno excimer trabeculotomy shows good IOP lowering effect, stability, Ocular Surgery News Vol. 12, No. 9 (2001) • Vogel M; Lauritzen K.: Selective Excimer Laser Ablation of the Trabecular Meshwork. Clinical Results. Ophthalmologe 94:665-667 (1997) •Walker R, Specht H: Theoretical and Physical Aspects of Excimer Laser Trabeculotomy (ELT) ab interno with the AIDA Laser Operating at a Wavelength of 308nm, Biomedizinische Technik Vol. 47, ELT is safe ELT is safe . . ELT ELT lowers IOP lowers IOP . . • Stealth: Non-thermal tissue removal • Less inflammation / scarring • More precise / titratable • Repeatable / No interference to other procedure • No blebs / No foreign bodies implanted • No hypotony / No pressure spikes • Pneumatic canaloplasty affects outflow • ELT effectively lowers IOP in the long- term and reduces medications • ELT is a logical adjunct to cataract surgery Evidence Level II Original

Transcript of No. of Meds ELT: Excimer Laser Trabeculostomy Clinical Update, 2009 Michael S. Berlin, MD, MS...

  • ELT: Excimer Laser TrabeculostomyClinical Update, 2009 Michael S. Berlin, MD, MS Glaucoma Institute of Beverly Hills, Jules Stein Eye Institute, UCLAProf. Ulrich Giers; Detmold, GermanyDr. Lea Kleineberg; Detmold, Germany Kevin Taliaferro, B.A., Glaucoma Institute of Beverly Hills

    Post-Op Single site coaxial Swan Jacob Osher Dual site1. Gonio Lenses 2. Endoscopes Conclusions Procedure

    A fiberoptic probe is introduced through a paracentesis to contact the trabecular meshwork & deliver non-thermal 308nm XeCl excimer laser energy to excise the trabecular meshwork, juxtacanalicular trabecular meshwork, and the inner wall of Schlemms canal without damaging the outer wall or the collector channels.

    No thermal damage to the TMResults Instrumentation

    1.) XeCl-Excimer Laser

    308 nm wavelength 1,2 mJ Application Energy 80 ns Pulse Length 20 Hz Repetition Rate

    2.) Fiber-Optic Delivery System : 3. Viewing the Meshwork Spot size : 200 m Application Energy : 1,2 mJ (~ 38 mJ/mm2) Tip Bevel : 65 Fiber Length : 2 m Tuilaser AIDAProf. Jens FunkProf. Ulrich Giers

    Prof. Potzche

    Osher LensSwan Jacob LensCoaxial Endoscope References Eyelight, Inc. 2009Technical patents are issued and pending. ELT is not yet available in the U.S. ELT in Phakic Eyes33 patients / 3 yearsGiers, Kleineberg, 2009Patent openings verified by induced blood reflux from Schlemms Canal 3 years after ELTPatent openings into Schlemms Canal intact 2.5 years after ELT Introduction

    ELT (Excimer Laser Trabeculostomy) is a minimally invasive, outpatient surgical procedure which corrects the anatomical pathology responsible for most open-angle glaucoma: outflow obstruction at the juxtacanalicular trabecular meshwork and the inner wall of Schlemms canal. ELT uses a 308 nm XeCl excimer laser to ablate the trabecular meshwork, increasing outflow within the eye by using Schlemms canal as the conduit, resulting in a significant and enduring decrease in IOP.

    ELT does not create a filtering fistula or bleb and the conjunctiva remains intact.

    ELT enables Pneumatic Canaloplasty. Non-thermal ablation turns tissue into gas, which validates continuity of flow between ablation sites, presumably via Schlemms canal. The gas is also anticipated to dilate Schlemms canal and collector channels, improving aqueous outflow.

    U. GiersU. GiersPneumatic Canaloplasty36% IOP reduction 91% Meds reduction Babighian S, Rapizzi E, Galan A; Efficacy and Safety of ab interno Excimer Laser Trabeculotomy in Primary Open-Angle Glaucoma: Two years of Follow-up; Ophthalmologica. 2006;220(5):285-90 Berlin, M.S. ELT, Excimer Laser Trabeculostomy Ocular Surgery News Vol. 19, no. 3, Feb 1, 2001 pp. 48-49 Berlin, M.S., Ahn, R. Perspectives on new laser techniques in managing glaucoma. Ophthalmology Clinics of North America, 8(2): 341-363, 1995 Berlin M: We need a trabecular meshwork procedure that works. American Glaucoma Society Annual Meeting, San Jose (2002) Berlin M, Funk J, Georgaras S, Giers U, Montrone F, Specht H, Welt R: ELT User Meeting, ESCRS Munich 2003 Berlin M: ELT Excimer Laser Trabeculostomy: Update 2003 ASCRS (2003) Berlin M, Funk J, Pache M, Wilmsmeyer S, Giers U, Kleineberg L, Ahmed I: Excimer Laser Trabeculostomy: A new, minimally invasive surgical procedure for the treatment of open-angle glaucoma, Glaucoma Today (2004) Berlin M, Taliaferro K: Excimer Laser Trabeculostomy: Normalizing IOP and Restoring Physiologic Outflow in Glaucoma, Glaucoma Today (2009) Funk J: Phako + ELT, DGII Ludwigshafen (2003) Funk J, Schlunck: Endoskopisch kontrolliert Er:YAG-Laser Gonoiotomie. Ophthalmologe. Jan;95(1):33-6 (1998) Grant WM. Experimental aqueous perfusion in enucleated human eyes. Archives of Ophthalmology 1963;69:783-801.

    Kaufmann R, Hibst R: Pulsed Er:YAG and 308nm UV excimer laser: an in vitro and in vivo study of skin-ablative effects. Laser Surg. Med. 9 (2) 132-140 (1989) Krasnov MM: Laseropuncture of anterior chamber angle in glaucoma.AmJOphthalmology 75:674-678 (1973) Montrone F, Pellicani L, Rana G, Pesce P: ELT RAZIONALE E METODICA ENDOSCOPICA, Glaucoma Up To Date, Bari (2003)Neuhann Th, Scharrer A, Haefliger E: Excimer laser trabecular ablation ab interno (ELT) in the treatment of open-angle glaucoma, Ophthalmo-Chirurgie 13:53-58 (2001) Neuhann Th, Scharrer A, Haefliger E: Laser ablation used to treat chronic open-angle glaucoma in pilot study, Ocular Surgery News Vol. 12, No. 11 (2001)Schrems W: Excimer Laser Trabekelablation ab interno, DOC Nrnberg (2002)Sourdille P: Study ab interno excimer trabeculotomy shows good IOP lowering effect, stability, Ocular Surgery News Vol. 12, No. 9 (2001) Vogel M; Lauritzen K.: Selective Excimer Laser Ablation of the Trabecular Meshwork. Clinical Results. Ophthalmologe 94:665-667 (1997)Walker R, Specht H: Theoretical and Physical Aspects of Excimer Laser Trabeculotomy (ELT) ab interno with the AIDA Laser Operating at a Wavelength of 308nm, Biomedizinische Technik Vol. 47, No. 5 106-110 (2002)

    ELT is safe. ELT lowers IOP.

    Stealth: Non-thermal tissue removal Less inflammation / scarring More precise / titratable Repeatable / No interference to other procedure No blebs / No foreign bodies implanted No hypotony / No pressure spikes Pneumatic canaloplasty affects outflow ELT effectively lowers IOP in the long-term and reduces medications ELT is a logical adjunct to cataract surgery

    Pt #AgeIOP Pre-opIOP 1 dayIOP 1 monthIOP 3 monthIOP 6 monthIOP 1 yearIOP 2 yearIOP 3 years152291419171718161825325131714141817173623615191921321824453391216191622222156115101617171213-62627151818182516187632013141516171513827291519192417181993423141619121918161029271212131412161711642812161919241520124426141616171718201382331215171818181614761813141217141514156024111414161515141653141014111010101117692013171318171910184436192022262219-19761810111112121411207022121316191516102179228111212111113226022121315131718122362261116161317181724442312151519161521252923111416151716172663171112131615161327622415161820181918287130121616192017162948257191412161916304829915131315201931453913182023231618326225111516181717-

    PT#AgeIOP pre-opIOP 1 dayIOP 1 monthIOP 3 monthsIOP 6 monthsIOP 1 yearIOP 2 yearsIOP 3 years186251421181716-2762216131614121311351382031191818232046622183311111211105832317181716141716683211318141812141078916101618141516128683717252023191619983281610111110111110782937182016131211782612171816201414128336816141812121813902010121515---147226151415121214-159032131416151711-

    PT#AgeIOP Pre-opIOP 1 dayIOP 1 monthIOP 3 monthsIOP 6 monthsIOP 1 yearIOP 2 yearIOP 3 year17817141111131212132792023141111111011382272811111210141447327121112111214135782618131217141614681211413141816151376919141311111111-8782814131816141514979188111113121211107723179910910101176271718141715131412722214111211111214137320131311111216151464201516111612121415782012161214161514167815131111131212Fistul. OP 07/061772171114131414141218712119161816151314198226171414171616152066262616131820161421731813121412121411226830301313161211-237118241814131813-248018101111101111-25811810101011910-2667101110101084-2778241019131211--287717121212121111-298323161715161620-308219111011121011-317119101316141611 -327118201111111114-33782291211161011-

    Evidence Level IIOriginal

  • Prof. Dr. E. Ltjen-Drecoll, Erlangen

    Chart3

    25.43756.36997746496.3699774649

    12.218752.32426714082.3242671408

    15.52.39623360382.3962336038

    15.781252.77935215242.7793521524

    16.68753.72816222133.7281622213

    17.43754.47889315244.4788931524

    16.56252.46180500262.4618050026

    16.17241379313.56640040133.5664004013

    IOP (mm Hg)

    Chart1

    25.43756.36997746496.3699774649

    12.218752.32426714082.3242671408

    15.52.39623360382.3962336038

    15.781252.77935215242.7793521524

    16.68753.72816222133.7281622213

    17.43754.47889315244.4788931524

    16.56252.46180500262.4618050026

    ELT long term follow-up

    IOP (mm Hg)

    Chart2

    25.43756.36997746496.3699774649

    12.218752.32426714082.3242671408

    15.52.39623360382.3962336038

    15.781252.77935215242.7793521524

    16.68753.72816222133.7281622213

    17.43754.47889315244.4788931524

    16.56252.46180500262.4618050026

    16.17241379313.56640040133.5664004013

    IOP (mm Hg)

    Excimer Laser Trabeculostomy

    Sheet1

    PT #Agepre op1 d1m3m6m1y2y3y# meds preop# meds 6m#meds1y#meds2y#meds3y

    GI-152291419171718161830000

    GI-253251317141418171730000

    GI-362361519192132182440100

    GI-453391216191622222141111

    GI-561151016171712131000

    GI-726271518181825161840011

    GI-963201314151617151340000

    GI-1027291519192417181940111

    GI-1234231416191219181631111

    GI-1329271212131412161720000

    GI-1464281216191924152050000

    GI-1544261416161717182030000

    GI-1682331215171818181600000

    GI-1776181314121714151420000

    GI-1960241114141615151440000

    GI-2053141014111010101101111

    GI-2269201317131817191010000

    GI-2344361920222622190001

    GII-276181011111212141120000

    GII-370221213161915161020110

    GII-47922811121211111310000

    GII-660221213151317181230000

    GII-862261116161317181700000

    GII-944231215151916152140000

    GII-1029231114161517161720000

    GII-1163171112131615161340001

    GII-1262241516182018191810000

    GII-1571301216161920171610000

    GII-174825719141216191620000

    GII-184829915131315201920000

    GII-1945391318202323161810000

    GII-2162251115161817171000

    Pre-op1 d1m3m6m1y2y3y

    mean55.3437525.437512.2187515.515.7812516.687517.437516.562516.17241379312.281250.093750.18750.218750.2068965517

    SD15.39922363986.36997746492.32426714082.39623360382.77935215243.72816222134.47889315242.46180500263.56640040131.46429273910.29614458110.39655776950.42001344060.4122508204

    Sheet1

    6.36997746496.3699774649

    2.32426714082.3242671408

    2.39623360382.3962336038

    2.77935215242.7793521524

    3.72816222133.7281622213

    4.47889315244.4788931524

    2.46180500262.4618050026

    3.56640040133.5664004013

    IOP (mm Hg)

    ELT as Monotherapy

    Sheet2

    Sheet3