“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.
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
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
2 2 (OD) 59 Female 13-Apr-06 5-Jul-08 27 months Breast
3 3 (OD) 66 Female 20-May-05 12-Jul-08 38 months Ovarian
3 4 (OS) 65 Female 11-Apr-05 12-Jul-08 39 months Ovarian
Eye # Antero- Keratometry Anterior Type of Preop. Subjective Postop.
posterior (D) chamber cataract BCVA** refraction BCVA
length depth (mm) Densitometry
+3.50 (-2 @
1 22.29 42.24 × 43.46 2.44 nuclear 20/100 88°) 20/20
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
• Photographs were analyzed for BIL centration with the Matlab 6.5
(MathWorks, MA, USA);
• After histopathological
processing, sections were
stained with Masson’s
• In each case, ultrasound examination revealed the presence of a well-
fixated, well-centered IOL located at the level of the capsular bag
Eye #1 Eye #2
Eye #3 Eye #4
• 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
maintained in each case,
without any distortion or
ovalization. The central
area delimitated by the
rhexis openings remained
perfectly clear in all eyes.
amounts of Soemmering’s
ring formation were Eye #3 Eye #4
observed from eyes 1 to 4
(Figure 4). Fig. 4
• 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).
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.
• 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
• 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
• 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
Site of adhesion
BIL between capsules
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.
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