related macular degeneration

158 Copyright © SLACK Incorporated

O R I G I N A L A R T I C L E

Initial Clinical Results of a New Telescopic IOL Implanted in Patients With Dry Age-Related Macular DegenerationFritz H. Hengerer, MD, PhD; Pablo Artal, PhD; Thomas Kohnen, MD, PhD; Ina Conrad-Hengerer, MD

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of the iol-AMD technology (London Eye Hospital Pharma, London, UK), which includes two injectable, hydrophobic acrylic intraocular lenses (IOLs) in a pilot study of patients di-agnosed as having cataract and dry age-related macular degeneration.

METHODS: The cataract surgery and IOL implantation were performed after a preoperative evaluation using the iolAMD simulator in eyes with bilateral intermediate dry age-related macular degeneration. Outcomes were intraoperative and postoperative complications, subjec-tive and objective visual acuity improvement, visual field changes, and postoperative diplopia.

RESULTS: Three eyes of 2 patients were evaluated. The surgeries were uneventful. All eyes gained mon-ocular reading vision at the 1-week postoperative visit. One patient with monocular implantation recognized diplopia for distance vision. Preoperative corrected dis-tance visual acuity ranged from 20/800 to 20/125 and corrected near visual acuity was 20/800 or less. Two months after surgery, corrected distance and near visual acuities increased to levels between 20/40 and 20/25 (uncorrected distance visual acuity was 20/60 to 20/32; uncorrected near visual acuity was 20/200 to 20/25).

CONCLUSIONS: These early results showed that the iolAMD simulator is a promising technology improving near and distance visual acuity in eyes with intermedi-ate dry macular degeneration. The prismatic IOL effect did not lead to diplopia when implanted bilaterally. The surgery was safely performed.

[J Refract Surg. 2015;31(3):158-162.]

ge-related macular degeneration (AMD) is the most common cause of irreversible, severe visual loss in the developed world in individuals older than 60

years. Approximately 10% of individuals between 65 and 75 years, and 30% of individuals older than 75 years suffer from this progressive disease. For patients with advanced AMD reading, driving and recognizing faces becomes more and more challenging and their visual acuity can decline to worse than 6/60.1-3 Most patients use magnifying spectacles or high power lenses in combination with bright light to increase the letter size and enhance the loss in contrast sensitivity in daily life. Limitations of binocular magnifying systems are decreases in peripheral visual field for orientation and higher magnifications leading to small central fields for perceiving the focused manuscript. Most spectacle-based systems are monocular telescopic approaches with varying magnification limited by their own weight.

Many concepts have been discussed recently to overcome the simultaneous problem of an aging macula in combina-tion with senile cataract. Previous attempts to solve this problem, for example the Intraocular Lens (IOL) for Visu-ally Impaired People-System, involved a more complex surgical procedure.4-7 This technology consists of two large, thick polymethylmethacrylate lenses. One is placed in the anterior chamber, the other in the capsular bag. Large cor-neal incisions of 7 to 8 mm in size are necessary due to the polymethylmethacrylate material. Potgieter and Claoué8 recently reported their initial clinical experience with the Fresnel prism IOL. This IOL is based on a polymethylmeth-acrylate platform with a Fresnel prism placed at its poste-

From the Department of Ophthalmology, Goethe-University Frankfurt, Frankfurt, Germany (FHH, TK); Laboratorio de Optica, Universidad de Murcia, Murcia, Spain (PA); and Department of Ophthalmology, Ruhr-University Bochum, Bochum, Germany (IC-H).

Submitted: December 7, 2014; Accepted: January 8, 2015

Dr. Artal is a consultant of London Eye Hospital Pharma. The remaining authors have no financial or proprietary interest in the materials presented herein.

Correspondence: Fritz H. Hengerer, MD, PhD, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. E-mail: [email protected]

doi:10.3928/1081597X-20150220-03

A

159Journal of Refractive Surgery • Vol. 31, No. 3, 2015

Telescopic IOL Approach With Dry AMD/Hengerer et al

rior surface that had been implanted in three eyes. Other technologies use combinations of intraocular implants with different powers to aim a telescopic ef-fect for magnifying. The iolAMD technology (London Eye Hospital Pharma, London, UK) is a new approach of two injectable, small-incision, hydrophobic acrylic IOLs. IOL 2 is a high-power minus lens placed into the capsular bag, whereas the IOL 1 is a high-power plus lens implanted into the sulcus. After implanta-tion they both act as a telescope, allowing a magni-fication of the image and distribution of the retinal picture 3° apart from the fovea due to the slight in-tended decentration of sulcus implanted IOL 1 (0.85 mm). The purpose of our study was to implant this IOL technology in 3 eyes of 2 patients with interme-diate dry AMD after cataract removal and to evaluate the efficacy and safety.

PATIENTS AND METHODSThe case series was reviewed by the local ethics

committee of Goethe-University Frankfurt and ap-proval was not needed due to the number of eyes and an implant with CE mark approval, respectively. All tenets of the Declaration of Helsinki were observed. Both patients had a visually significant cataract and in-termediate dry macular degeneration with drusen and volunteered for the study, providing signed informed consent. The exclusion criteria were pathologies that might be aggravated by the IOL or make it ineffective, other pathologies of the retina or cornea, glaucoma, pseudoexfoliation, zonular loss, or a history of uveitis.

Preoperatively, all enrolled patients underwent a full clinical examination including manifest refrac-tion, Snellen corrected distance and near visual acuity, noncontact partial coherence laser interferometry (IOL Master; Carl Zeiss Meditec, Jena, Germany), and an-terior segment imaging (Pentacam HR; Oculus Optik-geräte GmbH, Wetzlar, Germany). A fundus photogra-phy (Figure A, available in the online version of this article) and optical coherence tomography (Figures B-D, available in the online version of this article) ex-amination of the macula was performed. Furthermore, the iolAMD simulator was used for determination of the lens orientation.

The iolAMD lens system received CE mark approv-al in 2014 and is based on a Galileian telescope us-ing two lenses of differing power in minus and plus. Both lenses are manufactured from a hydrophobic acrylic material and can be injected with a standard soft tip cartridge and injector system for 3.0-mm in-cision size. The capsular bag positioned IOL (IOL 2) is a high-minus-power lens (-49 diopters [D]) with a 4.0-mm optic and an overall length of 11.0 mm. The

plate haptic is symmetrical and vaulted posteriorly ap-proximately 15°. The sulcus-positioned IOL (IOL 1) is a high-plus-power lens (+63 D) and the 5.0-mm hyper-aspheric-optic is slightly decentered on the plate hap-tic. The overall diameter is 11.75 to 12.0 mm and the haptic is bent anteriorly to enhance the recommended distance between the optics of 2 mm after implanta-tion. Both lenses have a refractive index of 1.525 and, in combination, the remaining refractive power of 21 D. The A-constant is estimated at 119.4. Magnification is provided up to 31.25.9

All eyes underwent small-incision phacoemulsi-fication using topical anesthesia. The two-step clear cornea main incision was placed at the 12-o´clock po-sition using a 2.2-mm metal keratome (Slit Knife 2.2 angled; Alcon Laboratories, Inc., Fort Worth, TX). The single-plane sideport incisions were placed at the 9- and 3-o´clock positions and made with a 1.2-mm metal keratome (Sideport Knife, dual bevel; Alcon Labora-tories, Inc.). After instillation of Healon 1% (Abbott Medical Optics, Inc., Santa Ana, CA) into the anterior chamber to protect the endothelium, the continuous curvilinear capsulorrhexis of an intended diameter of 5.0 mm was performed using Utrata capsulorrhexis forceps (Geuder, Heidelberg, Germany) through the main incision. Cataract surgery was performed using the Stellaris phacoemulsification machine (Bausch & Lomb, Aliso Viejo, CA) in all eyes. After flipping half the nucleus, further chopping under continuous phacoaspiration was performed. For removal of the remaining cortex, bimanual irrigation and aspiration through the nasal and temporal incisions were per-formed followed by polishing of the posterior capsule. After enlarging the corneal tunnel to 3.2 mm with a 3.2-mm metal keratome (Slit Knife, dual bevel, angled; Alcon Laboratories, Inc.) and a second instillation of ophthalmic viscosurgical device, the single-piece AMD 1 lens was implanted in the posterior chamber using an injector system. Afterward, the single-piece AMD 2 lens was also injected and positioned in the sulcus. According to the asymmetric haptic design, the optic of this lens was decentered toward the leading haptic and was aligned according to the preoperative evaluated axis. After carefully removing the ophthal-mic viscosurgical device, all eyes were covered with a patch. Standard topical ofloxacin and dexamethasone eye drops were administered four times daily for the first week, then the dosage gradually decreased over a period of 4 weeks. All surgeries were performed by the same surgeon (FHH) in July 2014.

The following endpoints were evaluated: (1) mani-fest refraction; (2) corrected and uncorrected distance visual acuity; (3) corrected and uncorrected near visual



acuity; (4) predicted corrected near visual acuity; (5) postoperative position of the lenses; and (6) in-traoperative and postoperative complications and adverse events.

StatiStical analySiSFor statistical analysis, the logMAR value of vi-

sual acuity was converted in decimal notation and vice versa, as described by Westheimer.10

RESULTSThe result of the preoperatively predicted near

visual acuity with this simulator was 20/200 to 20/100. In all 3 eyes, this visual acuity was gained 1 day after cataract surgery. During the 3-month follow-up, distance and near visual acuity in-creased. In 1 eye there was an increase of corrected near visual acuity of 20/32 and corrected distance visual acuity of 20/25. All detailed information is presented in Table 1.

Postoperative subjective refraction was 11.5 -0.5 3 135° D (patient 1), 11.0 D plano (right eye of patient 2), and -1.0 -0.75 3 95° (left eye of patient 2) at 3 months. For near visual acuity testing, we added 13.0 D of sphere.

Figure 1 shows the Pentacam analysis of the effective lens position at the 1-month follow-up examination of the left eye (patient 2). Figure 2 presents the IOLs position photographed by slit lamp and Figure E (available in the online version of this article) the left eye with a well-centered pu-pil and without any inflammation at the 3-month follow-up.

The patient with bilateral implantation per-ceived no double vision because the decentration axis in both eyes was vertical. The other patient with singular implantation recognized an increase in visual acuity but complained about diplopia in

TAB

LE 1

Pre

ope

rati

ve a

nd P

osto

pera

tive

Vis

ual

Re

sult

s, S

imul

ate

d E

xpe

cte

d Vi

sual

Acu

ity,

and

Sub

ject

ive

Re

frac

tion

Pre

oper

ativ

ePo

stop

erat

ive

Pati

ent

(Eye

)C

DVA

CN

VAP

redi

cted

C

NVA

Day

1

UD

VAD

ay 1

U

NVA

Day

4

UD

VAD

ay 4

U

NVA

Day

30

UD

VAD

ay 3

0 U

NVA

Day

30

CD

VAD

ay 3

0 C

NVA

Day

60

UD

VAD

ay 6

0 U

NVA

Day

60

CD

VAD

ay 6

0 C

NVA

Day

60

Sub

ject

ive

Ref

ract

ion

in

Dis

tanc

e (D

)

1 (le

ft)20

/800

(0

.03)

–20

/200

(0

.1)

20/2

00

(0.1

)20

/200

(0

.1)

20/1

60

(0.1

3)20

/160

(0

.13)

20/8

0 (0

.25

p)20

/80

(0.2

5)20

/50

(0.4

p)

20/4

0 (0

.5)

––

––

–

2 (le

ft)20

/400

(0

.05)

20/8

00

(0.0

3)20

/125

(0

.16)

20/1

00

(0.2

)20

/100

(0

.2)

20/1

00

(0.2

)20

/80

(0.2

5)20

/50

(0.4

)20

/32

(0.6

3 p)

20/3

2 (0

.63)

20/2

5 (0

.8 p

)–

––

––

2 (r

ight

)20

/125

(0

.16)

–20

/100

(0

.2)

20/6

0 (0

.33)

20/1

25

(0.1

6)20

/80

(0.2

5)20

/100

(0

.2)

20/8

0 (0

.25)

20/1

00

(0.2

)20

/50

(0.4

)20

/32

(0.6

3 p)

––

––

–

2 (b

inoc

ular

)–

––

––

––

20/4

0 (0

.5)

20/3

2 (0

.63)

20/2

5 (0

.8 p

)20

/25

(0.8

)–

––

––

1 (le

ft)–

––

––

––

––

––

20/4

0 (0

.5)

20/6

0 (0

.3)

20/3

2 (0

.63)

20/4

0 (0

.5)

11.

25 -

0.75

3 7

0°

2 (le

ft)–

––

––

––

––

––

20/4

0 (0

.5)

20/3

2 (0

.63)

20/2

5 (0

.8)

20/2

5 (0

.8)

-0.7

5 -0

.75

3 9

5°

2 (r

ight

)–

––

––

––

––

––

20/6

0 (0

.3)

20/1

00

(0.2

)20

/40

(0.5

)20

/32

(0.6

3)1

0.75

pla

no

2 (b

inoc

ular

)–

––

––

––

––

––

20/3

2 (0

.63)

20/2

5 (0

.8)

20/2

5 (0

.8)

20/2

5 (0

.8)

–

CDVA

= c

orre

cted

dis

tanc

e vi

sual

acu

ity;

CNVA

= c

orre

cted

nea

r vi

sual

acu

ity;

UD

VA =

unc

orre

cted

dis

tanc

e vi

sual

acu

ity;

UN

VA =

unc

orre

cted

nea

r vi

sual

acu

ity;

D =

dio

pter

s

Figure 1. Scheimpflug image of the two component intraocular lenses (IOL) 1 month after surgery.

161Journal of Refractive Surgery • Vol. 31, No. 3, 2015


a vertical direction. Orthoptic examination revealed a visual field deviation of 3°, which could be solved by prismatic spectacle correction for distance and near glasses. Furthermore, the visual acuity of the second eye with a monofocal single IOL was two lines above the eye with the telescopic implant.

complicationSAll surgeries were without complication and the

postoperative course of visual recovery was compa-rable with regular cataract surgery and implantation of only a single IOL in the capsular bag. There was no rise in intraocular pressure or iris-related problems such as shaving of pigment or pupillary block. The anterior chamber remained stable and the gap between both lenses provided the telescopic effect in all three eyes.

DISCUSSIONThis study was designed as a pilot study and 3 eyes

with intermediate dry AMD were included. Although the iolAMD simulator was used preoperatively for prediction of the postoperative near visual acuity, it showed predicted worse than 20/100 and all results obtained here were 20/40 to 20/25 (corrected distance visual acuity) after 3 months. This underestimation of the possible visual acuity may be related to the senile cataract lowering visual acuity by itself preoperatively. Furthermore, the iolAMD simulator is useful to predict the effective implantation axis prior to surgery. In our study, all lenses had been placed in a vertical axis and the IOL implantations could be obtained safely and were stable during the 3-month follow-up. No postop-

erative rotation was necessary. The possibility to rotate the sulcus IOL later in life could be an option to reestab-lish visual acuity, because the macular pathology is not a stable parameter. In case of further progress along this primary direction, the surgeon is able to simulate visual field rotation again if another direction of the implanta-tion axis can improve the previous effect and then ro-tate the sulcus lens according to this new location.

Other approaches currently under evaluation are lenses using a Fresnel prism on the posterior surface to relocate the field of retinal perception. This concept has shown to be effective in a recent pilot trial that contained eyes with late stage AMD.7

Until now, iolAMD lenses were designed hyper-aspheric to provide a large depth of focus. The combi-nation of a high-power minus 49-D lens placed in the capsular bag and a high-power plus 63-D lens arranged in the sulcus results optically in a Galileian telescope. Furthermore, the decentration of the plus lens allows a shift of the retinal focus of 5° along the axis. This item is important because there are no other power ranges available, limiting this technology to eyes with an axial length of 21 to 23 mm with a resulting power of 21 D. The IOL power cannot be adapted perfectly to patient anatomy right now.

Bilateral implantation can be recommended accord-ing to the underlying macular pathology to prevent dip-lopia in daily life situations. Proof of concept has been done with the patient receiving the iolAMD in 1 eye, because the other eye was pseudophakic. As a result of decentering the gained visual field, double vision was conspicuous and could be solved by prism correction.

Figure 2. Postoperative intraocular lens position of the (A) left eye of patient 1 and (B) right eye of patient 2 one month after surgery.

A B



The first implantations in this pilot study re-mained safe and showed restoration of both distance and reading visual acuity after cataract removal for 3 months of follow-up in patients with intermediate dry AMD. Further studies with more patients with dry AMD and long-term follow-up are currently un-der design to report on potential side effects over time in the future. Currently, only one IOL power is avail-able and a fixed angle of deviation of the visual field can be obtained. There is important scope for individ-ual optimization according to all patients with AMD and pseudophakic eyes, respectively. Other macular pathologies could also be potential options for im-plantation of this technology.

AUTHOR CONTRIBUTIONSStudy concept and design (FHH, PA); data collection (IC-H);

analysis and interpretation of data (FHH, TK, IC-H); drafting of the

manuscript (IC-H); critical revision of the manuscript (FHH, PA,

TK); statistical expertise (IC-H)

REFERENCES 1. Ferris FL, Davis MD, Clemons TE, et al. A simplified severity

scale for age-related macular degeneration: AREDS report No. 18. Arch Ophthalmol. 2005;123:1570-1574.

2. Lindblad AS, Clemons TE. Responsiveness of the National Eye Institute Visual Function Questionnaire to progression

to advanced age-related macular degeneration, vision loss, and lens opacity: AREDS Report no. 14. Arch Ophthalmol. 2005;123:1207-1214.

3. Olsen TW, Feng X. The Minnesota Grading System of eye bank eyes for age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004;45:4484-4490.

4. Orzalesi N, Pierrottet CO, Zenoni S, Savaresi C. The IOL-Vip System: A double intraocular lens implant for visual reha-bilitation of patients with macular disease. Ophthalmology. 2007;114:860-865.

5. Amselem L, Diaz-Llopis M, Felipe A, Artigas JM, Navea A, García-Delpech S. Clinical magnification and residual refrac-tion after implantation of a double intraocular lens system in patients with macular degeneration. J Cataract Refract Surg. 2008;34:1571-1577.

6. Khoramnia R, von Mohrenfels CW, Salgado JP, et al. The IOL-Vip system: Principles and clinical application [article in German]. Ophthalmologe. 2010;107:274, 276-280.

7. Singer MA, Amir N, Herro A, Porbandarwalla SS, Pollard J. Improving quality of life in patients with end-stage age-related macular degeneration: focus on miniature ocular implants. Clin Ophthalmol. 2012;6:33-39.

8. Potgieter FJ, Claoué CMP. Safety and efficacy of an intraocular Fresnel prism intraocular lens in patients with advanced macu-lar disease: initial clinical experience. J Cataract Refract Surg. 2014:40;1085-1091.

9. Artal P, Tabernero H, Scott JR, Qureshi BA. Intraocular mini-telescoope for AMD patients. Invest Ophthalmol Vis Sci. 2014;55.

10. Westheimer G. Scaling of visual acuity measurements. Arch Ophthalmol. 1979;97:327-330.

Figure A. Preoperative fundus photography of the (A) left and (B) right eye of patient 2.

A B

Figure B. Preoperative optical coherence tomography of the left eye of patient 1.

Figure C. Preoperative optical coherence tomography of the right eye of patient 2.

Figure D. Preoperative optical coherence tomography of the left eye of patient 2.

Figure E. Postoperative image of the left eye of patient 1 one month after surgery.

Reproduced with permission of the copyright owner. Further reproduction prohibited withoutpermission.

related macular degeneration

Documents