# Presentation: 875375

## Description of the Morcher® Capsular Tension Ring

- Invented 1991  by Dr. Bernd Witschel in Germany
- Purpose: 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 lenses
- IOL manufacturing : 1955 Dannheim lens; 1958 Binkhorst lens
- 1981 Introduced gamma sterilization
- 1987 Develops Compression Forge Method, allowing high fracture resistant, flexible PMMA
- International distribution
- Track 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”}
- 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 enrollment
- 240 eyes
- Further independent investigators
-  43 further surgeons
- 225 eyes enrolled

## Phase III

- Further patient enrollment by CORE Group investigators while PMA application pending
- 54 eyes at each of 4 sites

## Results: Efficacy

- Primary Measures:
- IOL centration
- Long-term stability
- Vitreous loss at surgery

## IOL centration

***Any clinically detectable decentration :***
- CORE Group, Phase I
- 	5 / 50  (10%) of eyes at 23-25 months
- CORE Group, Phase II
- 	12 / 157 (7.6%) of eyes at 11-13 months
- Independent Investigators, Phase II
- 	7 / 109  (6.4%) of eyes at 11-13 months

## Long-term stability

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

## Vitrectomy at surgeryExpected incidence without ring approaches 100%

- CORE Group, Phase I
- 		8 / 75 (13.3%)
- CORE Group, Phase II
- 		19 / 240 (7.9%)
- Independent Investigators, Phase II
- 		17 /225 (7.6%)

## Visual Acuity

- Visual acuity is not an appropriate outcome measure of the Morcher Capsule Tension Ring
- The 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 pathology

## Results: Safety

- Stability after Nd-YAG capsulotomy
- Inflammation
- Explantations
- Other post-op pathology

## Stability after Nd-YAG capsulotomy

- 3 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 10-14 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);
- No 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:
- 			Incidence			Persistent
- Iritis	  6 ( 1.2 %)		         0 ( 0 %)
- CME	 11 ( 2.1  %) 		4 ( 0.76 %)

## Technical Problems with Ring

- 540 total implants
- 		Broken eyelets			3
- 		Post-Op Extrusion		0
- 		Complications due to ring	0
- 		Infection				0
- 		Adverse Event			0
- 		Unable to fixate in bag	0

## Ring Explantations

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

## Retinal Detachments

- CORE Group, Phase I				3
- CORE Group, Phase I	I			5
- Independent Investigators, Phase II	0
- 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 II	5
- CORE: All patients had pre-existing glaucoma
- Independent: 2 pre-existing elevated IOP
- 			    1 PO Day 1 only
- 			    2 early postop only; 1 lost to f/u, 			1 pending longer f/u reports

## World-wide sales of the ring

- Year		CTRs sold		  Complaints
- 1992		      137			0
- 1993		    1420			0
- 1994		    1584			1
- 1995		    4796			0
- 1996		    5747			1
- 1997		    7808			0
- 1998		    9781			2
- 1999	           11,646			7
- 2000	           16,258			3
- 2001	           12,001	           	2

## Conclusions

- The 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 biocompatibility

## Conclusions

- The US Clinical trials under IDE G960190 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 IOL

## Conclusions

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