Corneal Crosslinking Without Epithelial Removal
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2 Corneal Crosslinking Without Epithelial Removal R. Doyle Stulting, MD, PhD 1 Jonathan Woolfson, MD 1 Bill Trattler, MD 2 Roy Rubinfeld, MD, MA 3 1 Woolfson Eye Institute, Atlanta, GA 2 Center for Excellence in Eye Care, Miami, FL 3 Re:Vision, Georgetown Univeristy and Washington Hospital Center, Washington, DC 2
3 Financial Disclosures Abbott Medical Optics Alcon Laboratories Avedro Calhoun Vision Cambium Medical Technologies CXL Ophthalmics EyeYon Hydrolenz Intelon Ocumetrics Ophtec Primisight TearLab 3
4 Financial Disclosures Abbott Medical Optics Alcon Laboratories Avedro Calhoun Vision Cambium Medical Technologies CXL Ophthalmics EyeYon Hydrolenz Intelon Ocumetrics Ophtec Primisight TearLab 4
5 Methods 5
6 Methods Prospective, observational study Novel riboflavin formulation and loading technique 1 Physician verification of riboflavin concentration, location, and homogenity at 20 min. with additional loading as needed (5-10 min) 12mm diameter light No riboflavin during UVA exposure Pulsed UVA 4 mw/cm 2 1 Patented riboflavin solution with optimized osmolarity, ph, concentration, nontoxic additive and delivery system developed by CXL Ophthalmics 6
7 Ex Vivo Rabbit Corneas Commercially Available Formulation CXLUSA Formulation ParaCel 4 min. and VibeX 6 min. per label CXLUSA formulation and loading sponges 10 min. Independent study performed by Absorption Systems, Inc., San Diego, CA, reported October 13, 2015
8 Ex Vivo Rabbit Corneas Commercially Available Formulation CXLUSA Formulation ParaCel 4 min. and VibeX 6 min. per label CXLUSA formulation and loading sponges 10 min. Independent study performed by Absorption Systems, Inc., San Diego, CA, reported October 13, 2015
9 Corneal Riboflavin Concentration (μg/g at min.) 35 Commercially Available Formulation (ParCel + VibeX) 35 CXLUSA Formulation Riboflavin Conc. µg/g Riboflavin Conc. µg/g Rabbit Rabbit Liquid chromatography/tandem mass spectrometry Independent study performed by Absorption Systems, Inc., San Diego, CA, reported October 13,
10 Inclusion Criteria Keratoconus, PMD, ectasia, FFKC 8-yo min. CT min : 300µ 10
11 Enrollment October 17, 2013-April 26, eyes with ectatic disease (10-65 yo)» Keratoconus: 512» Ectasia: 80» PMD: 16 CTmin: 302µ Database freeze 11/17/16 11
12 Interim Analysis Keratoconus or ectasia (excluding PMD)» 592 eyes total» 295 eyes with 12-month exams» 97 eyes with 24-month exams» 79 eyes (consistent cohort) with 3, 6, 12, and 24-month exams UCVA, MR, BSCVA, and Pentacam 12
13 Subject ATL-003 Keratoconus /400 UCVA (20/-) BSCVA (20/-) 15 yof /100 20/60 20/30 20/50 20/25 20/50 20/20 Preop Months After Surgery 13
14 12-Month Followup n=295 Parameter Preop 12 mos Change % UCVA (20/-) ~1line CDVA (20/-) ~1 line Kmax Total HOA Total Coma
15 Will We See Progression After One Year? 19% 23% Ricrolin TE Ricrolin TE Caporosi et al. JCRS 2013;391:1157 Soeters et al., AJO 2015;159:821 15
16 Visual Acuities Consistent Cohort at 24 Months /126 é UCVA ~1 1/2 lines é BSCVA ~1 1/2 lines 20/87 20/79 UCVA (20/-) BSCVA (20/-) No loss from 1-2 yr 20/82 20/ /34 20/28 20/28 20/27 20/25 0 Preop Months After Surgery N=79 16
17 Topography Consistent Cohort at 24 Months Kmax ê 0.54 D No increase from 1-2 years Preop Kmax (D) Kave (D) Zonal mean K (D) Months After Surgery N=79 17
18 High-Order Aberrations Consistent Cohort at 24 Months Mean RMS % Reduction in total HOA 42% Reduction in coma No increase from 1-2 years 0.0 Preop Total Coma Months After Surgery N=79 18
19 Subject ATL-003 OD 14 yof with Keratoconus /400 UCVA (20/-) BSCVA (20/-) /100 20/60 20/30 20/50 20/50 20/25 20/20 Preop Months After Surgery 19
20 Subject ATL-003 OD 14 yof with Keratoconus /400 UCVA (20/-) BSCVA (20/-) /100 20/60 20/30 20/50 20/25 20/50 20/20 20/50 20/20 Preop Months After Surgery 20
21 Subject ATL-003 OD 14 yof with Keratoconus Kmax ê 2.2 D 55 Diopters Continued decrease from 1-2 years Preop Kmax (D) Kave (D) Zonal mean K (D) Months After Surgery 21
22 Case Reports 22
23 Subject ATL yo hispanic female with KC Right Eye Visit Type UCVA BCVA Pre-Op 20/200 20/40 3 Months 20/40 20/40 6 Months 20/25 20/25 12 Months 20/25 20/25 12 months preop difference Left Eye Visit Type UCVA BCVA Pre-Op 20/80 20/30 3 Months 20/60 20/50 6 Months 20/40 20/25 12 Months 20/30 20/25 23
24 Subject ATL-078 OD Not treated OS CXL 5/8/14 20/20 BSCVA 4/15/14 20/40 BSCVA 2 ½ years 20/20 BSCVA 11/3/16 20/20 BSCVA 24
25 Re-Treatments 1 eye during study 1 eye after study 25
26 Subject ATL-054 OD 16 yom with Keratoconus 12 months 26
27 Subject ATL-054 OD 16 yom with Keratoconus UCVA (20/-) CDVA (20/-) /70 20/50 20/200 20/200 20/50 20/70 20/50 20/30 Retreatment Preop Months After Surgery 27
28 Subject ATL-054 OD 16 yom with Keratoconus UCVA (20/-) CDVA (20/-) /200 20/200 20/70 20/70 20/50 20/50 20/50 20/30 Retreatment Preop Months After Surgery 20/70 20/70 20/70 20/25 20/30 20/25 28
29 Subject ATL-054 OD 16 yom with Keratoconus 12 months after re-treatment 29
30 Subject ATL-028 OS 58 yof with Ectasia 24 months 30
31 Subject ATL-028 OS 58 yof with Ectasia /400 20/400 UCVA (20/-) CDVA (20/-) /200 20/200 20/100 20/40 20/30 20/40 20/30 20/40 Retreatment 0 Preop Months After Surgery 31
32 Subject ATL-028 OS 58 yof with Ectasia /400 20/400 UCVA (20/-) CDVA (20/-) /200 20/200 20/100 20/40 20/30 20/40 20/30 20/40 Retreatment 20/70 20/40 20/40 20/25 0 Preop Months After Surgery 32
33 Subject ATL-028 OS 58 yof with Ectasia 6 months after re-treatment 33
34 What About Eyes With An Increase In Kmax? 34
35 CDVA When Kmax >1D at 12 mos /297 eyes at 12 months with Kmax > 1D Number of Eyes lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 35
36 CDVA When Kmax >1D at 12 mos 7 6 Average gain of 1.1 lines Number of Eyes n= lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 36
37 CDVA When Kmax >1D at 12 mos Number of Eyes No eyes with Kmax > 1D and loss of >1 line CDVA n= lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 37
38 CDVA When Kmax >1D at 24 mos Number of Eyes /97 eyes at 24 months with Kmax > 1D 0 4 lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 38
39 CDVA When Kmax >1D at 24 mos Number of Eyes Average gain of 1.1 lines n= lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 39
40 CDVA When Kmax >1D at 24 mos Number of Eyes No eyes with Kmax > 1D and loss of >1 line CDVA n= lines worse 3 lines worse 2 lines worse 2 Lines Worse 1 Line Worse Equal to PreTx CDVA 1 Line BeAer 2 Lines BeAer 3 lines beaer 4 lines beaer 40
41 Adverse Events 41
42 Adverse Events ATL-051 OD Hydrops» 1 eye with ectasia at 23 months» Underwent PK UCVA CDVA Kmax 1 Preop 20/400 20/ months 20/400 20/ Data gaps on all Pentacam exams 42
43 Adverse Events ATL-185 OS Scleritis» 1 eye with KC at 3 weeks» Responded to oral steroids UCVA CDVA Kmax Preop 20/50 20/ months 20/30 20/
44 Adverse Events ATL-037 OD Disciform edema» 1 eye with KC at 15 mos» On Valtrex 500 mg qd for oral HSV» Responded to Valtrex 1 gm BID and topical steroids UCVA CDVA Kmax Preop 20/400 20/ months 20/400 20/
45 Conclusions Epi-on CXL using CXLO technologies halts progression of ectatic corneal disease without loss of effect between 1 and 2 years Improvement in CDVA is similar to that with epioff CXL No complications of epithelial removal No eyes with > 1D increase in Kmax and loss of > 1 line CDVA No AE s resulting in visual loss Kmax may not be best metric for evaluating CXL 45
46 Thank You 46
47 Differences In Technique BAC or Tris + EDTA No physician assessment of saturation Riboflavin during UVA exposure 9 mm diameter light Continuous UVA 3 mw/cm 2 Novel riboflavin formulation 1 Physician SL verification and saturation as needed No riboflavin during UVA exposure 12 mm diameter light Pulsed UVA 4 mw/cm 2 1 Patented riboflavin with optimized osmolarity, ph, concentration, non-toxic additive and delivery system developed by CXL Ophthalmics 47
48 Demarcation Lines CXLUSA 0.1% Riboflavin + THAM + EDTA Filipello, JCRS 2012;38:238 Photo Courtesy of Dan Goodman, MD 48
49 Slit Lamp Grading System Grade 0/V Grade I/V 49
50 Slit Lamp Grading System Grade II/V Grade III/V 50
51 Slit Lamp Grading System Grade IV/V Grade V/V 51
52 Slit Lamp Grade Slit Lamp Grade Commercially Available Formulation (ParaCel, VibeX Xtra) 3 Rabbits 4 Rabbits Slit Lamp Grade CXLUSA Formulation Minutes Minutes 52
53 SLE vs Riboflavin Concentration Riboflavin Conc. µg/g Slit Lamp Grade 53
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