Description of the MorcherDescription of the Morcher®® Capsular Tension RingCapsular Tension Ring• Invented 1991 by Dr. Bernd Witschel in Invented 1991 by Dr. Bernd Witschel in

GermanyGermany

• Purpose: Enhance mechanical stability of Purpose: Enhance mechanical stability of the lens capsule in the presence of weak or the lens capsule in the presence of weak or absent zonulesabsent zonules

Mechanism of Stabilization:Mechanism of Stabilization:Recruitment of Adjacent ZonulesRecruitment of Adjacent Zonules

Posterior ViewPosterior View

Brief history of Morcher GmbHBrief 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 IOL manufacturing : 1955 Dannheim lens; 1958

Binkhorst lensBinkhorst lens• 1981 Introduced gamma sterilization1981 Introduced gamma sterilization• 1987 Develops Compression Forge Method, 1987 Develops Compression Forge Method,

allowing high fracture resistant, flexible PMMAallowing high fracture resistant, flexible PMMA• International distributionInternational distribution• Track record of the Capsule Tension Ring is Track record of the Capsule Tension Ring is

consistent with the highest standards of consistent with the highest standards of manufacturing qualitymanufacturing quality

Indication for Use of the Capsule Indication for Use of the Capsule Tension Ring Tension Ring

Stabilization of the crystalline lens capsule Stabilization of the crystalline lens capsule in the presence of weak or absent in the presence of weak or absent zonules. Typical conditions include zonules. Typical conditions include pseudoexfoliation, prior trauma, prior pseudoexfoliation, prior trauma, prior pars plana vitrectomy, and Marfan’s pars plana vitrectomy, and Marfan’s SyndromeSyndrome

IDE Study Design: Phase IIDE Study Design: Phase I

• 5 sites / 11 surgeons 5 sites / 11 surgeons {the “CORE Group”}{the “CORE Group”}

– 75 eyes enrolled75 eyes enrolled

– 2 year follow-up period2 year follow-up period

The CORE GroupThe CORE GroupI. Howard Fine, M..D., Eugene, OR I. Howard Fine, M..D., Eugene, OR Medical MonitorMedical MonitorHarry B. Garbow, M.D., Sarasota, FLHarry B. Garbow, M.D., Sarasota, FLMinnesota Eye Consultants, Minneapolis, MNMinnesota Eye Consultants, Minneapolis, MN

Richard L. Lindstrom, M.D.Richard L. Lindstrom, M.D.David R. Hardten, M..D.David R. Hardten, M..D.Thomas W. Samuelson, M.D.Thomas W. Samuelson, M.D.Yun-Sen Ralph Chu, M.D.Yun-Sen Ralph Chu, M.D.

Cincinnati Eye InstituteCincinnati Eye InstituteRobert H. Osher, M..D.Robert H. Osher, M..D.Robert J. Cionni, M..D.Robert J. Cionni, M..D.Michael E. Snyder, M.D.Michael E. Snyder, M.D.James D. Faulkner, M.D. James D. Faulkner, M.D.

Roger F. Steinert, M.D. Boston, MARoger F. Steinert, M.D. Boston, MA

Phase IIPhase II

Two groups:Two groups:

• CORE Group with additional patient CORE Group with additional patient enrollmentenrollment

– 240 eyes240 eyes

• Further independent investigatorsFurther independent investigators

– 43 further surgeons43 further surgeons

– 225 eyes enrolled225 eyes enrolled

Phase IIIPhase III

• Further patient enrollment by CORE Group Further patient enrollment by CORE Group investigators while PMA application investigators while PMA application pendingpending

– 54 eyes at each of 4 sites54 eyes at each of 4 sites

Results: EfficacyResults: Efficacy

Primary Measures:Primary Measures:

• IOL centrationIOL centration

• Long-term stabilityLong-term stability

• Vitreous loss at surgeryVitreous loss at surgery

IOL centrationIOL centration

Any clinically detectable decentration :Any clinically detectable decentration :

• CORE Group, Phase ICORE Group, Phase I

5 / 50 (10%) of eyes at 23-25 months 5 / 50 (10%) of eyes at 23-25 months

• CORE Group, Phase IICORE Group, Phase II

12 / 157 (7.6%) of eyes at 11-13 months 12 / 157 (7.6%) of eyes at 11-13 months

• Independent Investigators, Phase IIIndependent Investigators, Phase II

7 / 109 (6.4%) of eyes at 11-13 months7 / 109 (6.4%) of eyes at 11-13 months

Long-term stabilityLong-term stability

• 9 reports of decentration of IOLs9 reports of decentration of IOLs

• At last report:At last report:

– 1 eye 2mm1 eye 2mm

– 8 eyes 1mm or less8 eyes 1mm or less

• No reports of extrusion of the ring from the No reports of extrusion of the ring from the capsular bagcapsular bag

Vitrectomy at surgeryVitrectomy at surgeryExpected incidence without ring Expected incidence without ring

approaches 100%approaches 100%

• CORE Group, Phase ICORE Group, Phase I

8 / 75 (13.3%)8 / 75 (13.3%)

• CORE Group, Phase IICORE Group, Phase II

19 / 240 (7.9%)19 / 240 (7.9%)

• Independent Investigators, Phase IIIndependent Investigators, Phase II

17 /225 (7.6%)17 /225 (7.6%)

Visual AcuityVisual Acuity

• Visual acuity is not an appropriate outcome Visual acuity is not an appropriate outcome measure of the Morcher Capsule Tension measure of the Morcher Capsule Tension RingRing

• The Ring is not an IOLThe Ring is not an IOL

• The cases in which the Ring is implanted The cases in which the Ring is implanted are are selectedselected for a high rate of pre-op and for a high rate of pre-op and intra-op pathology intra-op pathology

Results: SafetyResults: Safety

• Stability after Nd-YAG capsulotomyStability after Nd-YAG capsulotomy

• InflammationInflammation

• ExplantationsExplantations

• Other post-op pathologyOther post-op pathology

Stability after Nd-YAG capsulotomyStability after Nd-YAG capsulotomy

• 3 reports of possible new or increased decentration 3 reports of possible new or increased decentration after Nd-YAG laser capsulotomyafter Nd-YAG laser capsulotomy– 1 eye reported as “slight” decentration pre-1 eye reported as “slight” decentration pre-

YAG; YAG at 4 m; and 2mm post-YAGYAG; YAG at 4 m; and 2mm post-YAG– 1 eye reported as 1mm decentration at first 1 eye reported as 1mm decentration at first

report post YAG at 10-14 w exam but no report post YAG at 10-14 w exam but no decentration thereafterdecentration thereafter

– 1 eye had YAG vitreolysis to strand and 1 eye had YAG vitreolysis to strand and anterior capsulotomy at 7 weeks; decentration anterior capsulotomy at 7 weeks; decentration reported as:reported as:

2mm (10-14w); 0.5mm (22-26w); 0mm (11-2mm (10-14w); 0.5mm (22-26w); 0mm (11-13m); 1mm (23-25m);13m); 1mm (23-25m);

• No cases of extrusion of the ring after laser No cases of extrusion of the ring after laser capsulotomycapsulotomy

InflammationInflammation

FDA raises issue of biocompatibility of the FDA raises issue of biocompatibility of the PMMA used in the ring. Possible clinical PMMA used in the ring. Possible clinical correlations of the 524 patients with reports correlations of the 524 patients with reports from 1 week to closure:from 1 week to closure:

IncidenceIncidence PersistentPersistent

• IritisIritis 6 ( 1.2 %) 6 ( 1.2 %) 0 ( 0 %) 0 ( 0 %)

• CMECME 11 ( 2.1 %) 11 ( 2.1 %) 4 ( 0.76 %)4 ( 0.76 %)

Technical Problems with RingTechnical Problems with Ring

540 total implants540 total implants

Broken eyeletsBroken eyelets 33

Post-Op ExtrusionPost-Op Extrusion 00

Complications due to ringComplications due to ring 00

InfectionInfection 00

Adverse EventAdverse Event 00

Unable to fixate in bagUnable to fixate in bag 00

Ring ExplantationsRing Explantations• 540 implants540 implants• 8 explantations (1.5%)8 explantations (1.5%)

– 7 during primary surgery7 during primary surgery• Procedural complicationsProcedural complications 2 2• Inadequate capsule or zonules to support Inadequate capsule or zonules to support

ring ring 4 4• Incorrect ring sizeIncorrect ring size 1 1

– 1 at 1 week postop due to unstable capsule 1 at 1 week postop due to unstable capsule

Retinal DetachmentsRetinal Detachments

CORE Group, Phase ICORE Group, Phase I 33

CORE Group, Phase ICORE Group, Phase I II 55

Independent Investigators, Phase IIIndependent Investigators, Phase II 00

5 RDs present preop5 RDs present preop

2 immediate postop; unclear whether also 2 immediate postop; unclear whether also preoppreop

1 2 years postop1 2 years postop

Elevated IOPElevated IOP

CORE Group, Phase ICORE Group, Phase I 22CORE Group, Phase II CORE Group, Phase II 99Independent Investigators, Phase IIIndependent Investigators, Phase II 55

CORE: All patients had pre-existing CORE: All patients had pre-existing glaucomaglaucoma

Independent: 2 pre-existing elevated IOPIndependent: 2 pre-existing elevated IOP 1 PO Day 1 only1 PO Day 1 only 2 early postop only; 1 lost to 2 early postop only; 1 lost to

f/u, f/u, 1 pending longer f/u 1 pending longer f/u reportsreports

World-wide sales of the ringWorld-wide sales of the ringYearYear CTRs soldCTRs sold Complaints Complaints19921992 137 137 0019931993 1420 1420 0019941994 1584 1584 1119951995 4796 4796 0019961996 5747 5747 1119971997 7808 7808 0019981998 9781 9781 2219991999 11,646 11,646 7720002000 16,258 16,258 3320012001 12,001 12,001 22

ConclusionsConclusions

• The Morcher capsule tension ring has been The Morcher capsule tension ring has been in use for one decadein use for one decade

• The ring is available throughout the world The ring is available throughout the world and enjoys consistently positive clinical and enjoys consistently positive clinical reports, absence of complications reports, absence of complications attributable to the ring, and long term attributable to the ring, and long term stability and biocompatibilitystability and biocompatibility

ConclusionsConclusions

• The US Clinical trials under IDE G960190 The US Clinical trials under IDE G960190 reflect the worldwide positive experience reflect the worldwide positive experience with the Morcher ringwith the Morcher ring

• The capsule tension ring effectively The capsule tension ring effectively stabilizes the capsular bag in cases of weak stabilizes the capsular bag in cases of weak or partially absent zonules, reducing the rate or partially absent zonules, reducing the rate of serious complications such as vitreous of serious complications such as vitreous loss, dislocation of the nucleus, and loss, dislocation of the nucleus, and inability to implant a PC IOLinability to implant a PC IOL

ConclusionsConclusions

• No safety concerns about the ring have No safety concerns about the ring have arisen in the course of the IDE trialarisen in the course of the IDE trial

• No alternative device or technique exists to No alternative device or technique exists to achieve these clinical objectivesachieve these clinical objectives