CROSS LINKING: ITALIAN RESULTS

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Amerigo Vaccaro
6 anni fa
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1 University of Siena - Italy Department of Ophthalmology Head: Prof. Aldo Caporossi MD, FRCS Siena Eye Cross Project CROSS LINKING: ITALIAN RESULTS A. Caporossi MD, FRCS S.Baiocchi MD,PhD C.Mazzotta MD, PhD C. Traversi MD First Italian CCL Abilitating Course Siena 2 february 2007

2 Italian Cross-Linking Study Group Coordinator: Prof. Aldo Caporossi Siena University: Prof. A. Caporossi Eye Cross Group Rome Catholic University: Prof. Emilio Balestrazzi Bari University: Prof. C. Sborgia, Prof. G. Alessio Florence University: Prof. U. Menchini, Dr R. R Mencucci L Aquila University: Prof. Leopoldo Spadea Milan Humanitas Clinic (ICH): Prof. Paolo Vinciguerra Napoli II University: Prof. Mario Bifani Venezia Hospital: Dott. Giancarlo Caprioglio

3 CCL: Inclusion criteria Age: >14 (better if < 35 years) Demonstrated clinical, topographycal, pachometrycal or aberrometrical KC worsening in the last 6-12 months Preserved BSCVA (>20/40) Small spherical defect (Better if less than D) Clinical and Confocal Clear cornea Very well informed patients!!!! CCL: Esclusion criteria Demonstrated clinical, topographycal, pachometrycal or aberrometrical KC stability in the last 24 months Orbscan (Pentacam) preoperative thinnest point < 400 µm Evidence of subepithelial or mid-anterior stromal scar or opacities Slit lamp evidence of marked Vogt striae or Confocal evidence of deep reticular pattern dark bands Age <14 or >35 years

4 Demographic and Pre-operative data Treated eyes: 34 (19 right eyes/15 left eyes) Follow up > 12 months: 20 eyes Gender: Men 21 Women 13 (15 5) Mean Age: 23,18 years (from 14 to 42 years) All patients were affected from progressive Keratoconus clinically and instrumentally documented in the last 6 months (7 stage 1, 23 stage 2, 2 stage 3) All patients underwent corneal collagen cross-linking by combined use of riboflavin-uva according Italian protocol (Dresden modified standars) Preop, 15 dd, 1,3,6,12,18 and 24 months evaluation m US Pachimetry: 441,5 µ (from 406 to 488 µ) m IOP: 13,9 mmhg (from 11 to 18 mm Hg) m Endothelial cells count: 2216c / mm 2 a. s. Follow-up: min. 6 months (mean 11,6 m 6/26)

5 UVA power-meter Cross-linking of keratoconus protocol and surgical timing Solution: Riboflavin (vitamin B2) 0,1% - Dextrane 20% UVA Source: solid state UVA led -370 nm Energy-dose: 3 mw/cm²= 5,4 J/cm² (checked with UVA meter) Exposure Time: 30 min Distance from corneal surface: 1 cm -1.8 cm Epithelial removal (blunt spatula): 9 mm diameter B 2 0.1% dextrane B 2 0.1% dextrane B 2 0.1% dextrane B 2 0.1% dextrane B 2 0.1% dextrane B 2 0.1% dextrane B 2 0.1% dextrane Ofloxacin t (min) UVA Exposition

6 Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS ( CROSS-LINKING of Keratoconus by RIBOFLAVIN UVA: First and last case treated Eye Clinic University of Siena Prof. A. CAPOROSSI EPITHELIAL ABRASION CBMXlinker UVA IRRADIATION 30 MIN En 3 mw/cm2 = 5,4 J/CM2

7 Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS ( UVA Source evolution TIP T0-46 BALL LENS Double UVA-LED Five LEDs Array CSO CBM XLinker CBM XLinker: CE Labeled

8 Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS ( RIBOFLAVIN 0,1% SOLUTION - Ricrolin SOOFT Italia Siena EYE Cross Project: A. Caporossi, C. Mazzotta, S. Baiocchi, C. Traversi

9 Preoperative refractive data Sphere Cylinder S E (1-21 patients with follow-up up>12m)

10 Preoperative functional 1 performances 0,9 0,8 0,7 0,6 0,5 0,4 0,3 UCVA SSpCVA BSCVA 0,2 0, patients with follow-up up>12m

11 Preoperative and follow-up course of IOP, CCT and Endothelial Cells Count ,5 463,3 452,8 453,6 453,8 451,6 460 IOP CCT ECC ,9 13,7 13,9 14,5 14,2 14, Preop 1 m 2 m 3 m 6 m 12 m 24 m (34 e) (20 e) (6 e) Paired t-test: N.S. statistically difference in the follow-up for anolyzed data

12 CCL: Complications Early Corneal Oedema (15dd/3m) 12/34 Delayed reepith. (>6 dd) 00/34 Loss > 2 snellen (in the first 3 m) 03/34 Slit lamp Corneal Haze 05/34 Corneal Melting 00/34 Hypertone 00/34 Endothelial Damage 00/34

13 Early onset Haze After CCL Dexametazone phospate 0.1% Preservative free 4/d tapered in 40 days A.C.: 17 y.o. 40 days after CCL A.C.: 17 y.o. 3 months after CCL All cases improved after Steroids

14 CCL: Complications Late Late onset Haze 01/34 Loss > 2 snellen in BSCVA 00/34 Persistent Epithelial defect 00/34 Corneal Melting 00/34 Hypertone 00/34 Endothelial Damage 00/34 Keratoconus Progression 00/34

15 Late onset Haze After CCL Dexametazone phospate 0.1% Preservative free 4/d tapered in 40 days and Diclofenac Sodium preservative free 3/d for 40 days M.L.: 23 y.o. 90 days after CCL M.L.: 17 y.o. 6 months after CCL

16 Mean functional performances in the follow up 0,7 UCVA 0,6 0,5 0,4 0,3 0,2 0,1 0 Preop 1 M 2 M 3 M 6 M 12 M SSCVA BSCVA Media Mobile su 2 per. (BSCVA) Media Mobile su 2 per. (SSCVA) Media Mobile su 2 per. (UCVA)

17 Functional Outcomes m UCVA Pre-op m UCVA 3m post m UCVA 12 m post 1,6/10-20/125 (1/30-5/10) (20/600-20/40) 3,9/10-20/52 (1/10-10/10) (20/200-20/20) 4,5/10 20/45 (1/10-10/10) (20/200-20/20) m BCVA Pre-op m BCVA 3m post m BCVA 6m post 4,4/10 20/46 (2/10-10/10) (20/100-20/20) 6/10 20/33 (4/10-10/10) (20/50-20/20) 6,6/10 20/30 (4/10-10/10) (20/50-20/20)

18 Mean K course during follow-up K min Ave 52 Mean K Ave K Max Ave Preop 1 M 2 M 3 M 6 M 12 M Media Mobile su 2 per. (K min Ave) Media Mobile su 2 per. (Mean K Ave) Media Mobile su 2 per. (K Max Ave)

19 The reduced mean K can explaine the increased UCVA but only the increased symmetry of the cornea help to explaine the improvement in BSCVA. According to Wollensak, Seiler and Spoerl, We introduced CCL in Italy in the 2004 at Siena University

20 Corneal Simmetry after CCL MS: preop SI = 4.57 MS: postop 18m SI = 2.99

21 Symmetry index 14,00 12,00 10,00 y = -0,3902x + 6,1483 R 2 = 0,9141 8,00 6,00 4,00 2,00 0,00 Pre 1m 2m 3m 6m 12 m

22 Keratoconic induced optical effects APEX TILTING PRISMATIC EFFECT COMA SECONDARY-ASTIGMATISM CORNEAL RAY DECREASING INCREASED DIOPTRIC POWER OF THE ANTERIOR SURFACE MIOPIC SHIFT CORNEAL THINNING REDUCED CURVATURE EFFECT HYPEROPIC SHIFT DECREASED POSTERIOR CURVATURE RAY REDUCED CORNEAL POWER

23 Corneal Wavefront: Summary 4,5 4,0 3,5 3,0 2,5 2,0 1,5 1,0 0,5 0,0 y = -0,2551x + 4,3847 R 2 = 0,799 y = -0,1851x + 2,9013 R 2 = 0,8682 y = 0,0074x + 0,8773 R 2 = 0,03292 Pre 1m 2m 3m 6m 12m HOA Coma Sph Ab. Lineare (HOA) Lineare (Coma) Lineare (Sph Ab.)

24 Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS ( Corneal Surface COMA Before and after CCL PL: Postop 3 m PL: Preop PL: postop 6 m PL: post 12 m

25 Cross-Linking: Konus stability or mid term efficacy? Preop Preop 6m 6m 12m 12m 18m 18m 24m 24m 36m 36m A.Caporossi, S Baiocchi, C. Mazzotta et Al JCRS 2006

26 Summary Some side effects was observed >2 D Mean K topographic reduction Mean 2.7 Snellen lines improved UCVA Mean1.9 Snellen lines improved BSCVA Over 70% improved Corneal Simmetry Significant reduction in Comatic Corneal Aberration No topographical and functional regression after 24 months f.u.

27 Conclusions CCL prevent and reduce corneal biomechanical worsening CCL improve Corneal optical properties CCL is an encouraging therapeutical option in early KC stages to delay KC progression

28 Attention!! CCL is NOT a refractive procedure, but have some refractive stables positive effects CCL is a stabilizing treatment that increase corneal simmetry

29 Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (

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