Description of the Morcher ® Capsular Tension Ring Invented 1991 by Dr. Bernd Witschel in GermanyInvented 1991 by Dr. Bernd Witschel in Germany Purpose: Enhance mechanical stability of the lens capsule in the presence of weak or absent zonulesPurpose: Enhance mechanical stability of the lens capsule in the presence of weak or absent zonules

Mechanism of Stabilization: Recruitment of Adjacent Zonules

Posterior View

Brief history of Morcher GmbH Founded in 1943 as manufacturer of contact lensesFounded in 1943 as manufacturer of contact lenses IOL manufacturing : 1955 Dannheim lens; 1958 Binkhorst lensIOL manufacturing : 1955 Dannheim lens; 1958 Binkhorst lens 1981 Introduced gamma sterilization1981 Introduced gamma sterilization 1987 Develops Compression Forge Method, allowing high fracture resistant, flexible PMMA1987 Develops Compression Forge Method, allowing high fracture resistant, flexible PMMA International distributionInternational distribution Track record of the Capsule Tension Ring is consistent with the highest standards of manufacturing qualityTrack record of the Capsule Tension Ring is consistent with the highest standards of manufacturing quality

Indication for Use of the Capsule Tension Ring Stabilization of the crystalline lens capsule in the presence of weak or absent zonules. Typical conditions include pseudoexfoliation, prior trauma, prior pars plana vitrectomy, and Marfan’s Syndrome

IDE Study Design: Phase I 5 sites / 11 surgeons {the “CORE Group”}5 sites / 11 surgeons {the “CORE Group”} –75 eyes enrolled –2 year follow-up period

The CORE Group I. Howard Fine, M..D., Eugene, OR Medical Monitor Harry B. Garbow, M.D., Sarasota, FL Minnesota Eye Consultants, Minneapolis, MN Richard L. Lindstrom, M.D. David R. Hardten, M..D. Thomas W. Samuelson, M.D. Yun-Sen Ralph Chu, M.D. Cincinnati Eye Institute Robert H. Osher, M..D. Robert J. Cionni, M..D. Michael E. Snyder, M.D. James D. Faulkner, M.D. Roger F. Steinert, M.D. Boston, MA

Phase II Two groups: CORE Group with additional patient enrollmentCORE Group with additional patient enrollment –240 eyes Further independent investigatorsFurther independent investigators – 43 further surgeons –225 eyes enrolled

Phase III Further patient enrollment by CORE Group investigators while PMA application pendingFurther patient enrollment by CORE Group investigators while PMA application pending –54 eyes at each of 4 sites

Results: Efficacy Primary Measures: IOL centrationIOL centration Long-term stabilityLong-term stability Vitreous loss at surgeryVitreous loss at surgery

IOL centration Any clinically detectable decentration : CORE Group, Phase ICORE Group, Phase I 5 / 50 (10%) of eyes at months CORE Group, Phase IICORE Group, Phase II 12 / 157 (7.6%) of eyes at months Independent Investigators, Phase IIIndependent Investigators, Phase II 7 / 109 (6.4%) of eyes at months

Long-term stability 9 reports of decentration of IOLs9 reports of decentration of IOLs At last report:At last report: –1 eye 2mm –8 eyes 1mm or less No reports of extrusion of the ring from the capsular bagNo reports of extrusion of the ring from the capsular bag

Vitrectomy at surgery Expected incidence without ring approaches 100% CORE Group, Phase ICORE Group, Phase I 8 / 75 (13.3%) CORE Group, Phase IICORE Group, Phase II 19 / 240 (7.9%) Independent Investigators, Phase IIIndependent Investigators, Phase II 17 /225 (7.6%)

Visual Acuity Visual acuity is not an appropriate outcome measure of the Morcher Capsule Tension RingVisual acuity is not an appropriate outcome measure of the Morcher Capsule Tension Ring The Ring is not an IOLThe Ring is not an IOL The cases in which the Ring is implanted are selected for a high rate of pre-op and intra-op pathologyThe cases in which the Ring is implanted are selected for a high rate of pre-op and intra-op pathology

Results: Safety Stability after Nd-YAG capsulotomyStability after Nd-YAG capsulotomy InflammationInflammation ExplantationsExplantations Other post-op pathologyOther post-op pathology

Stability after Nd-YAG capsulotomy 3 reports of possible new or increased decentration after Nd-YAG laser capsulotomy3 reports of possible new or increased decentration after Nd-YAG laser capsulotomy –1 eye reported as “slight” decentration pre- YAG; YAG at 4 m; and 2mm post-YAG –1 eye reported as 1mm decentration at first report post YAG at w exam but no decentration thereafter –1 eye had YAG vitreolysis to strand and anterior capsulotomy at 7 weeks; decentration reported as: 2mm (10-14w); 0.5mm (22-26w); 0mm (11- 13m); 1mm (23-25m); 2mm (10-14w); 0.5mm (22-26w); 0mm (11- 13m); 1mm (23-25m); No cases of extrusion of the ring after laser capsulotomyNo cases of extrusion of the ring after laser capsulotomy

Inflammation FDA raises issue of biocompatibility of the PMMA used in the ring. Possible clinical correlations of the 524 patients with reports from 1 week to closure: IncidencePersistent Iritis 6 ( 1.2 %) 0 ( 0 %)Iritis 6 ( 1.2 %) 0 ( 0 %) CME 11 ( 2.1 %) 4 ( 0.76 %)CME 11 ( 2.1 %) 4 ( 0.76 %)

Technical Problems with Ring 540 total implants Broken eyelets3 Post-Op Extrusion0 Complications due to ring0 Infection0 Adverse Event0 Unable to fixate in bag0

Ring Explantations 540 implants540 implants 8 explantations (1.5%)8 explantations (1.5%) –7 during primary surgery Procedural complications 2Procedural complications 2 Inadequate capsule or zonules to support ring 4Inadequate capsule or zonules to support ring 4 Incorrect ring size 1Incorrect ring size 1 –1 at 1 week postop due to unstable capsule

Retinal Detachments CORE Group, Phase I3 CORE Group, Phase II5 Independent Investigators, Phase II0 5 RDs present preop 2 immediate postop; unclear whether also preop 1 2 years postop

Elevated IOP CORE Group, Phase I 2 CORE Group, Phase II 9 Independent Investigators, Phase II5 CORE: All patients had pre-existing glaucoma Independent: 2 pre-existing elevated IOP 1 PO Day 1 only 1 PO Day 1 only 2 early postop only; 1 lost to f/u, 1 pending longer f/u reports 2 early postop only; 1 lost to f/u, 1 pending longer f/u reports

World-wide sales of the ring YearCTRs sold Complaints , , ,001 2

Conclusions The Morcher capsule tension ring has been in use for one decadeThe Morcher capsule tension ring has been in use for one decade The ring is available throughout the world and enjoys consistently positive clinical reports, absence of complications attributable to the ring, and long term stability and biocompatibilityThe ring is available throughout the world and enjoys consistently positive clinical reports, absence of complications attributable to the ring, and long term stability and biocompatibility

Conclusions The US Clinical trials under IDE G reflect the worldwide positive experience with the Morcher ringThe US Clinical trials under IDE G reflect the worldwide positive experience with the Morcher ring The capsule tension ring effectively stabilizes the capsular bag in cases of weak or partially absent zonules, reducing the rate of serious complications such as vitreous loss, dislocation of the nucleus, and inability to implant a PC IOLThe capsule tension ring effectively stabilizes the capsular bag in cases of weak or partially absent zonules, reducing the rate of serious complications such as vitreous loss, dislocation of the nucleus, and inability to implant a PC IOL

Conclusions No safety concerns about the ring have arisen in the course of the IDE trialNo safety concerns about the ring have arisen in the course of the IDE trial No alternative device or technique exists to achieve these clinical objectivesNo alternative device or technique exists to achieve these clinical objectives