Transcript Diapositiva 1 - Giuseppe Migliorati

ARVO Meeting
Fort Lauderdale,
Florida, USA
May 2-6, 2010
Poster: D939
Visual and refractive outcomes after implantation
of a new intraocular lens: 6-month follow-up.
Giuseppe Migliorati, Maria L. Salvetat, Marco Zeppieri and Paolo Brusini
Department of Ophthalmology, S. Maria della Misericordia Hospital, Udine, Italy.
Introduction Since Ridley’s original idea in 1949, several artificial intraocular lens (IOL) types have been designed to optimize visual outcomes
Results All surgeries were completed within a time period of 10 minutes. No intraoperative complications were observed.
after cataract surgery.1 Modern research in this field is centred on IOL design and material that have optical properties similar to the natural,
transparent, young human lens. New IOLs are currently being designed to reduce postoperative complications, such as optical aberrations,
decentration, tilting, posterior capsular opacification (PCO), and risk of retinal detachment.2,3
The “Apeiron” 42F is a new IOL designed by GM, produced by Morcher GmbH, and commercially available since 2009 (Fig.1). It is an acrylic
hydrophilic foldable IOL with a 6 mm optics and an external circular loop diameter of 11 mm; the loops are angled at 22° (Fig.2). It can be folded
and inserted through a 2.2 mm clear corneal incision (CCI) (Fig.3).
Purpose: To evaluate visual acuity (VA), refractive outcomes, optic IOL position and postoperative complications after implantation of the new
foldable Apeiron 42F Morcher IOL.
0.9 ± 0.1
33
0.5 ± 0.5
0,6
0.6
0,4
0.4
pre-op
Fig.4
post-op
The
mean
BCVA
significantly improved 6 months
postoperatively compared to the
preoperative data (p=0.0001).
0,6
0.6
0,4
0.4
0,2
0.2
0,0
0.0
pre-op
post-op
00
-1
-1
-2
-2
2183 ± 321
pre-op
post-op
2400
2200
2000
-3
-3
-4
-4
pre-op
post-op
-5
-5
cells/ mm
0,0
0.0
0,8
0.8
Diopters
0,2
0.2
2256 ± 303
11
2
0.37 ± 0.2
-0.75 ± 0.4
2600
1,0
1.0
0,8
0.8
2800
22
1,2
1.2
1,0
1.0
-0.9 ± 2.0
0.6 ± 0.4
Corneal endothelial cell density
cells/mm2
1,4
Diopters
-The 11-mm diameter external circular loop may provide a better centration inside the capsular bag, which is important in postoperative visual
outcome. IOL decentration usually gives rise to coma-like aberrations.2
-The 22° angle between the IOL optic disc and the external circular loop is similar to that found between the equator and the posterior pole in the
human crystalline lens, which may limit the anterior displacement of the vitreous body, thus reducing the risk of vitreo-retinal tractions or retinal
ruptures;7
- The foldable IOL insertion through a small CCI tends to minimize surgically induced astigmatism and optical aberrations, resulting in better
postoperative visual outcomes.8
Manifest refractive spherical equivalent
Refractive astigmatism
1,2
Decimal notation
The new “Apeiron” 42F Morcher IOL theoretically
provides several advantages:
- The hydrophilic acrylic material has shown to provide
high uveal biocompatibility.4
- The square-edge optic design has shown to decrease
the development of PCO due to the reduced space
between the IOL and the posterior capsule. This may
limit lens epithelial cell proliferation and metaplasia;5 the
issue, however, remains controversial.6
Best corrected visual acuity
diopters
Fig.2. Technical characteristics of the 42F IOL.
diopters
Fig.2
Snellen lines
Fig.1. “Apeiron” 42F Morcher IOL
1800
1600
Fig.5 The RA did not change
Fig.6 A tendency toward a slight Fig.7 The mean ECD loss 6
significantly 6 months
surgery (p=0.47).
hyperopic refractive error was
observed 6 months after surgery.
after
months after surgery was 3.3 ±
3.4% (range 0.5 – 11.6%)
compared to pre-op data (p=0.02).
Fig.8A.
UBM image of a cataractous
crystalline lens before surgery. Fig.8B. A
traditional IOL posizionated inside the capsular
bag in the fellow eye. Fig.8C. The “Apeiron”
42F Morcher IOL positioned inside the
capsular bag at 6 months after surgery.
All UBM images taken 6 months after surgery
showed good IOL centration in the capsular
bag and posterior optic displacement.
The mean distance between the endothelium and the IOL optic posterior surface 6 months post-op was 6.1 ± 0.5 mm (range 5.2 – 6.5).
Fig.8
A
B
C
Conclusions This preliminary study shows that the new “Apeiron” 42F IOL seems to be an effective and safe surgical alternative to traditional
Fig.3 The “Apeiron” 42F IOL is folded and inserted in the capsular bag through a CCI of 2.5 mm.
Methods This prospective surgical study included 25 eyes of 25 consecutive subjects (mean age of 71±12 years, range 55-86) undergoing
cataract extraction with phacoemulsification and implantation of an IOL in the capsular bag.
Biometry was performed with the IOLMaster optical biometer (Carl Zeiss Meditec AG). IOL power was chosen to obtain an emmetropic
postoperative refraction. The same experienced surgeon (PB) performed all surgeries using a standardized technique and peribulbar anesthesia.
The technique included a temporal 2.5 mm CCI, continuous curvilinear capsulorhexis of 5.5 mm, phacoemulsification, and IOL “Apeiron” 42F
(Morcher GmbH, Stuttgart, Germany) implantation in the capsular bag with a 2.2 mm cartridge system (Microglide injector, Medicel AG,
Switzerland) (Fig.3). Best corrected VA (BCVA), manifest refractive spherical-equivalent (MRSE), refractive astigmatism (RA), and corneal
endothelial cell density (ECD) were assessed 6 months postoperatively and compared with the preoperative values using the paired Student t-test.
The MRSE and RA were evaluated with the Automatic Refractor/Keratometer 599 (Zeiss Humphrey, Dublin, CA). ECD was assessed using the
non-contact specular microscope Tomey EM-3000 (Tomey, Japan). Postoperative IOL position was assessed with the ultrasound biomicroscopy
(UBM) (Vumax 2, Sonomed Inc., NY,USA) using a 35 MHz transducer probe.
Financial disclosure: GM is the inventor of the new IOL. The authors have no financial interest in any devices used in the study.
IOLs. It provided favorable clinical performances, which included ease of implantation, minimal postoperative uveitis, and good optic centration.
BCVA significantly improved after surgery in all cases without significantly induced astigmatism. The slight postoperative hyperopic refractive error
induce by the IOL is probably due to the posterior optical axial displacement.9 A modified proposed constant may reduce the surgically induced
refractive error. No eyes showed postoperative visually significant anterior capsule contraction or PCO. This IOL is advantageous in that it
completely distends the capsular bag, which theoretically reduces IOL dislocation and PCO, thus providing an excellent barrier between the
anterior and posterior eye segment. Moreover, the posterior position of the IOL, which is provided by the large angle between the optic disc and
the loops, should limit the posterior vitreous from moving forward, thus reducing the risk of postoperative retinal detachment. Further long-term
multicenter studies with this new IOL are needed to determine the rate of postoperative complications, especially PCO and retinal detachment.
References
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9. Erikson P. Effects of intraocular lens position errors on post-operative refractive error. J Cataract Refract Surg 1990;16:305-311.