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					“Pathological Assessment of the First Human
  Eyes Obtained Postmortem Implanted with
         the Bag-In-The-Lens Design”

              Liliana Werner, MD, PhD1
       Marie-José Tassignon, MD, PhD, FEBO2
                   Brian Zaugg, MS1

1 JohnA. Moran Eye Center, University of Utah, Salt Lake City, UT, USA
2 Department of Ophthalmology, Antwerp University Hospital, Belgium



-Tassignon is the inventor of the bag-in-the-lens IOL. The other authors have no financial or proprietary
interest in any product mentioned in this poster.
-Supported in part by the Research to Prevent Blindness Olga Keith Wiess Scholar Award, and a Funding
Incentive Seed Grant of the University of Utah Research Foundation (Liliana Werner, MD, PhD), as well as
by the Funds for Research in Ophthalmology, Belgium (Marie-José Tassignon, MD, PhD, FEBO).
-The Bag-In-The-Lens IOL is not FDA approved.
                          Background
 The “bag-in-the-lens” (BIL) concept involves the use of a twin
 capsulorhexis lens design, and performance of anterior and posterior
 capsulorhexes of the same size (Figure 1). According to this concept,
 if both capsules are well stretched around the optic of the lens, any
 remaining lens epithelial cells (LECs) will be captured within the
 remaining space of the capsular bag, and their proliferation will be
 limited to this space, so the visual axis will remain clear.1-9 The BIL has
 been patented in Europe and in the United States. It received
 European CE mark approval in 2004 and it has been implanted in over
 2,000 eyes in Europe, India, and South Africa (2000-2008).


Fig. 1                             BIL
                                                         LECs


  The aim of this study was to describe, for the first time, clinico-
  pathological findings of human eyes obtained postmortem
  implanted with the foldable hydrophilic acrylic BIL design.10
                          Patients and Methods: 1
 Patient #    Eye #        Age at         Gender        Date of       Date of    Postoperative    Cause of
                         implantation                 implantation    death          time          death
    1         1 (OD)         86            Male         5-Jun-07     12-Oct-07     4 months         Lung
                                                                                                   cancer
    2         2 (OD)         59           Female       13-Apr-06     5-Jul-08     27 months        Breast
                                                                                                   cancer
    3         3 (OD)         66           Female       20-May-05     12-Jul-08    38 months       Ovarian
                                                                                                  cancer
    3         4 (OS)         65           Female       11-Apr-05     12-Jul-08    39 months       Ovarian
                                                                                                  cancer

  Eye #       Antero-    Keratometry      Anterior      Type of       Preop.       Subjective     Postop.
             posterior       (D)          chamber       cataract      BCVA**       refraction      BCVA
              length                     depth (mm)   Densitometry
               (mm)*
                                                                                  +3.50 (-2 @
    1          22.29     42.24 × 43.46      2.44         nuclear      20/100          88°)         20/20
                                                        posterior
                                                       subcapsular
    2          23.53     42.56 × 43.06      3.65         cataract      20/50           -3          20/20
                                                        cortical                 +1.50 (-0.50 @
    3          22.21     43.06 × 43.57      2.67        cataract       20/70          77°)         20/20
                                                        cortical                 +2.25 (0.25 @
    4          22.13     42.62 × 43.34      2.71        cataract      20/100          98°)         20/20

* Measured with IOL Master (Zeiss, Germany). ** BCVA = Best-corrected visual acuity.
                  Patients and Methods: 2
• All lenses were the Morcher (Stuttgart, Germany) type 89A, single-
  piece, hydrophilic acrylic BIL (28% water content); the surgical
  procedure was described elsewhere;1-8
• The eyes were enucleated, immersed in 10% neutral buffered formalin,
  and sent to the John A. Moran Eye Center;
• They underwent anterior segment scanning with a very-high frequency
  ultrasound system with digital enhancement (Artemis, Ultralink LLC, St.
  Petersburg, FL, USA) (Figure 2);
• After coronal section, gross analyses were done from the posterior or
  Miyake-Apple view;
• Photographs were analyzed for BIL centration with the Matlab 6.5
  (MathWorks, MA, USA);
• After histopathological
  processing, sections were
  stained with Masson’s
  trichrome stain.
                         Fig. 2
                           Results: 1

• In each case, ultrasound examination revealed the presence of a well-
  fixated, well-centered IOL located at the level of the capsular bag
  (Figure 3).




 Eye #1                                                           Eye #2




 Eye #3                                                           Eye #4


                                Fig. 3
                              Results: 2
• Gross           examination
  showed fibrosis of the
  rhexis      edges,      more
  prominently      in     eyes
  number 2-4 (postoperative
  time: 27 to 39 months).
  The overall round shape of
  the capsular bag was                     Eye #1
                                                    Eye #2
  maintained in each case,
  without any distortion or
  ovalization. The central
  area delimitated by the
  rhexis openings remained
  perfectly clear in all eyes.
  Progressively          larger
  amounts of Soemmering’s
  ring     formation      were             Eye #3   Eye #4
  observed from eyes 1 to 4
  (Figure 4).                     Fig. 4
                                    Results: 3

• Analyses of the gross
  photographs      with   the
  Matlab     6.5*     showed
  minimal degrees of BIL
  decentration in relation to
  the capsular bag and the
  pupil (Figure 5).

                                  Fig. 5

   Eye #   Capsular      Pupil    Average space in   Decentration in     Decentration in
              bag      diameter   the capsular bag   relation to the   relation to the pupil
           diameter                   periphery       capsular bag
     1       9.52        4.09           2.26             0.033                0.026
     2       9.78        4.26           2.39             0.161                0.213
     3       9.62        3.08           2.31             0.301                0.532
     4       9.71        3.73           2.36             0.157                0.036
   *All measurements in mm.
                            Results: 4

• Although some degree of artifactual disruption of the relationship
  between the lens and the capsular bag due to tissue processing and
  sectioning was observed in each case, histopathological sections
  passing through the center of the capsular bag showed anterior and
  posterior capsule openings directed to the groove at the periphery of
  the lens (Figures 6-8).
                          Fig. 6; Eye number 1




                                       Anterior capsule

                  BIL

                                                          Posterior capsule
                                Results: 5

• Progressively larger amounts of Soemmering’s ring formation,
  composed of cortical material and pearls were observed in the eyes
  with longer follow up. However, any regenerative/proliferative material
  would remain confined to the intercapsular space of the capsular bag
  remnant outside the optic rim/groove (Figures 7 and 8).

                              Fig. 7; Eye number 2



                     Soemmering’s ring    Anterior capsule




        BIL



                                            Posterior capsule
                                  Results: 6

• A tissue composed of LECs and fibrosis was present on the inner
  surface of the anterior capsule, apparently mediating adhesion between
  anterior and posterior capsules at the rhexis sites (more clearly
  observed in eyes number 2-4) (Figure 8).



                                Fig. 8; Eye number 3

                                                      Anterior capsule



                  Soemmering’s ring


                                            Site of adhesion
        BIL                                 between capsules




                                                  Posterior capsule
                  Discussion / Conclusions
•    The donor eyes analyzed in our study, which represent unique
     specimens had different postoperative times after BIL implantation.
     Our results confirm the BIL concept:
1.   The special design of the BIL renders its centration and postoperative
     stability primarily dependent on the position of the 2 capsulorhexes.
     Decentration of the lens in relation to the center of the capsular bag, and
     to the center of the pupil was insignificant in the specimens described
     here, but can be improved by new alignment devices.
2.   It appears that a fibrocellular tissue develops during the first
     postoperative year on the inner surface of the anterior rhexis margin
     (rhexis fibrosis), which mediates adhesion between anterior and posterior
     capsules at that site, inside the IOL groove. This probably helps
     enhancing the postoperative stability of the lens.
3.   When anterior and posterior capsules are properly secured in the
     peripheral groove of the IOL, any proliferative/regenerative material
     remains confined to the intercapsular space of the capsular bag remnant
     outside the optic rim. Therefore, the visual axis remains clear.
                                      References

1.    Tassignon MJ, De Groot V, Vrensen GF. Bag-in-the-lens implantation of intraocular lenses. J
      Cataract Refract Surg 2002; 28:1182-1188.
2.    De Groot V, Tassignon MJ, Vrensen GF. Effect of bag-in-the-lens implantation on posterior capsule
      opacification in human donor eyes and rabbit eyes. J Cataract Refract Surg 2005; 31:398-405.
3.    Tassignon MJ, De Groot V, Van Tenten Y. Searching the way out for posterior capsule opacification.
      Verh K Acad Geneeskd Belg 2005; 67:277-288. Review.
4.    De Groot V, Leysen I, Neuhann T, Gobin L, Tassignon MJ. One-year follow-up of bag-in-the-lens
      intraocular lens implantation in 60 eyes. J Cataract Refract Surg 2006; 32:1632-1637.
5.    Leysen I, Coeckelbergh T, Gobin L, et al. Cumulative neodymium:YAG laser rates after bag-in-the-
      lens and lens-in-the-bag intraocular lens implantation: comparative study. J Cataract Refract Surg
      2006; 32:2085-2090.
6.    Tassignon MJ, De Veuster I, Godts D, et al. Bag-in-the-lens intraocular lens implantation in the
      pediatric eye. J Cataract Refract Surg 2007; 33:611-617.
7.    Verbruggen KH, Rozema JJ, Gobin L, et al. Intraocular lens centration and visual outcomes after
      bag-in-the-lens implantation. J Cataract Refract Surg 2007; 33:1267-1272.
8.    Tassignon MJ, Rozema JJ, Gobin L. Ring-shaped caliper for better anterior capsulorhexis sizing and
      centration. J Cataract Refract Surg 2006; 32:1253-1255.
9.     De Keyzer K, Leysen I, Timmermans JP, Tassignon MJ. Lens epithelial cells in an in vitro capsular
      bag model: lens-in-the-bag versus bag-in-the-lens. J Cataract Refract Surg 2008; 34:687-695.
10.   Werner L, Tassignon MJ, Gobin L, et al. Bag-in-the-lens: First pathological analysis of a human eye
      obtained postmortem. J Cataract Refract Surg 2008; 34:2163-2165.

				
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