Special Publication: Ophthalmochirurgie Supplement 2/2009 (Original printed issue available in the German language)

Transcription

1 Special Publication: Ophthalmochirurgie Supplement 2/2009 (Original printed issue available in the German language) LENTIS Mplus - The one -and and-only Non--rotationally Symmetric Multifocal Lens Multi-center clinical trial conducted under the leadership of Professor Dr. Gerd U. Auffarth at the study center Heidelberg All of the multifocal intraocular lenses (MIOL) developed since the 1990s are rotationally symmetric and are either based on the principles of diffraction and/or refraction of the light or on a combination of these two principles. They distribute the incoming light rays to two principal focal points, a near vision focus and a distance vision focus or to several foci. However, as the transition between the different optical surfaces is not always seamless, the incoming light rays will be broken on the sector edges of diffractive MIOLs. In case of most conventional MIOLs, this effect will lead to severe visual disturbance, including increased glare sensitivity, poor contrast perception and impaired night vision. On the occasion of the Congress of German Ophthalmic Surgeons 2009 in Nuremberg, Oculentis has started the market launch of its novel multifocal intraocular lens. By its innovative unique design which allows for seamless transitions between the near and far vision zones thus reducing light sensations to a minimum, this lens features a completely new approach in multifocal lens technology. Fig.1: LENTIS Mplus Rendering and REM-footage: A one-piece multifocal acrylic lens made of HydroSmart material with posterior surface asphericity and a large sector-shaped near-vision zone. Another important feature is the 360-degree continuous square optic and haptic edge to reduce the risk of posterior capsule opacification.

2 With a reported rate of 95 percent, clinical trials already confirm a very high degree of patient satisfaction with implantation of the multifocal LENTIS Mplus (Fig. 1), along with its excellent contrast sensitivity and minimum glare properties. In March 2009, this MIOL has received CE Mark approval. Technical Information: Acrylic lens made from HydroSmart material providing an innovative optical operating principle Compared to the current state-of-the-art in multifocal lens technology, this MIOL stands out for its functional design which is unique in the world and for its optical operating principle: An aspheric, asymmetric far-vision zone is combined with a sector-shaped near-vision zone of diopters allowing for seamless transition between the far and near vision zones. In particular, glare and "image jumps" caused by reflections as often experienced in twilight or in central headlight glare conditions will thus be avoided (Figure 2). Fig.2.: LENTIS Mplus Non-rotationally symmetric multifocal lens with a sector-type near-vision zone (a) Side view on the non-rotationally symmetric multifocal sector-type lens: The lens is constructed by combining two spherical surfaces with different radii; one main surface with a radius R 1 and an embedded surface with a radius R 2. (b) View on the lens towards the optical axis, topographic view: The embedded surface forms a sector-type segment in the area of the angle and the radial area r. (a) and (b) The centers of curvature of the two surfaces are on the Z-axis, i.e. on the optical axis of the sector lens. The vertexes of both surfaces coincide with the origin O. Consequently, both principal foci of the lens are on its optical axis. Thus, an image displacement will not be possible.

3 The design principle of the surface-embedded sector segment makes the MIOL independent of the pupil size. (Figure 4) This embedded sector segment ensures optimum adjustment of near and distance vision acuity. Another distinctive feature of the lens is that the light - when it hits the transition area to the embedded sector element - will be reflected away from the optical axis. This prevents any superposition of interference/diffraction normally caused by curvature variations on optical surfaces. On the one hand, it will result in a minor loss of light intensity; on the other hand, however, in significantly improved contrast sensitivity. Thanks to this unique patented optic design no ghost or double images are propagated and significantly less glare and/or halo effects appear. The well-proved HydroSmart acrylic material used since 1996 already guarantees excellent biocompatibility. Moreover, the successful LENTIS design ensures high stability in the capsular bag. Fig. 3: Light propagates along the Z-axis in direction of the reference planes P 1, P 2, P 3 thus forming two focal points allowing for clear near and distance visual acuity with smooth transition. Fig. 4.: Light propagation of LENTIS Mplus. Amount of incoming light depends on the pupil size. In case of narrow pupil, light rays will be propagated almost exclusively by the far-vision zone; in case of a 4-mm pupil aperture 50 % by the far-vision zone and 40% by the near-vision zone.

4 Clinical Trials: More than 100 Eyes Included Patients and Methods In a multi-center clinical trial conducted under the leadership of Professor Dr. Gerd U. Auffarth at the study center Heidelberg as well as at the centers in Pardubice and Poznan, the Oculentis LENTIS Mplus lens was implanted into 119 eyes of 72 patients until February of The mean age of the study participants (36 men and 36 women) came to 67 ± 12 years, with a minimum age of 22 years and a maximum age of 87 years. The study parameters followed up after one and three months included: visual acuity, contrast perception, glare and halos, postoperative use of spectacle lenses, refraction, patient satisfaction, positioning and handling, complications and side effects as well as postoperative vision. Postoperative Visual Acuity and Refraction Mean power of the implanted multi-focal intraocular lenses came to / dpt. Three months after surgery, best-corrected mean ETDRS distance visual acuity was 0.01 logmar, and uncorrected near visual acuity was 0.08 logmar (for further information, refer to Table 1). This is equivalent to a distance visual acuity and a near visual acuity of 0.99 and 0.83, respectively. Postoperative refraction values are shown in Figure 5. BCDVA after (study period) BCDVA [logmar] Minimum Maximum BCDVA [decimal] 3 months 0.01 [ ] 0.99 ± month 0.07 [ ] 0.86 ± UCNVA after (study period) UCNVA [logmar] Minimum Maximum UCNVA [decimal] 3 months 0.08 [ ] 0.83 ± month 0.13 [ ] 0.74 ± N N Table 1: Best-corrected distance visual acuity and uncorrected near vision acuity, one month and three months after surgery.

5 Refractive Outcome with LENTIS MPlus One Month and Three Months after Implantation Study Centers 1 month after implantation; in total N=102 3 months after implantation; in total N=95 Figure 5: Refraction values, one month and three months after surgery Glare and Halos In the course of a patient satisfaction survey, 60 study participants were interviewed. Compared to similar MIOL models, patients implanted with the LENTIS Mplus lens experienced less halos and/or glare effects. On impulse, halos were reported by 10 percent of these patients. On special inquiry, 22 percent confirmed having experienced halos; however, only 15 percent of all interviewed patients were able to specify the halo effect in more detail. On impulse, three percent of the patients reported glare effects. Lens Positioning and Lens Handling A prerequisite for the best possible effect of the LENTIS Mplus lens is positioning of its optical axis on the line of vision of the eye as well as inferior positioning of the sectorshaped reading zone. In the course of the study, no case of decentration, tilting or displacement of the MIOL exceeding 5 has been reported. This speaks in favor of an easy intra-operative handling of the LENTIS Mplus lens (surgery took between 7.6 +/- 2min and /- 2.6 min) and of its stable positioning in the capsular bag. Undesirable Events and Complications All reported complications were not caused by the lens itself. Three patients (5 eyes) experienced complications which results in a complication rate of 4.7 percent. Thereof, at the follow-up examination after one month two patients were diagnosed with cystoid macular oedema and one patient with an accumulation of viscoelastics fluid behind the lens having led to transient myopia. At the three months follow-up examination, two patients were cured but one patient with macular oedema still needed further treatment.

6 Contrast Sensitivity of LENTIS Plus 3 Months after Implantation In respect to contrast perception, the results are equivalent to those of a 20-year-old person obtained with LENTIS Mplus are very good and with healthy eyes (Figure 6). Spatial frequency (cpd) LENTIS Mplus, CSV-1000, N=49 Normal population, years Pre-op, CSV-1000, N=39 Normal population, years Normal population, years Figure 6: Visual performance of LENTIS Mplus. The contrast sensitivity of the LENTIS Mplus lens is equivalent to this of a 20-yearold person (logcs = Logarithm of contrast sensitivity is plotted against the spatial frequency; cpd = cycles per degree or periods per degree or cycles/ ). Patient Satisfaction The rate of patient satisfaction determined by means of a questionnaire is very high. Ninety percent of the patients would choose a LENTIS Mplus lens again, 5 percent were undecided and another 5 percent decided against the lens. It should be pointed out that the far-above-average patient satisfaction with the novel MIOL made by Oculentis was seen very early after surgery already (3 months postoperatively). This speaks in favor of a very short adaption period and an excellent spontaneous tolerability of the LENTIS Mplus lens.

7 Tab. 2: Patient Satisfaction Patient Satisfaction, 3 months after implantation. N=60 Distance visual acuity At home 1.3 Assessment Daylight/Street 1.4 Very good 1 Night/twilight 1.5 Good 2 Near visual acuity At home 1.3 Fair 3 Daylight/Street 1.4 Poor 4 Night/twilight 1.5 Satisfied with the Right eye 1.4 operated eye Left eye 1.4 Would you choose the Yes 54 Pat. 90 % same lens type again? No 3 Pat. 5 % Undecided 3 Pat. 5 % Ghost images 0 Pat. 0 % Double vision 0 Pat. 0 % Halos On impulse 6 Pat. 10 % On inquiry 13 Pat. 22 % Glare effects On impulse 2 Pat. 3 % On inquiry 6 Pat. 10 % Color shift 0 Pat. 0 % Distortion 0 Pat. 0 % Blurring On impulse 5 Pat. 8 % On inquiry 1 Pat. 1.7 % Summary: LENTIS Mplus a novel innovative multifocal lens principle yield ing an excellent functional outcome and a very high rate of patient satisfaction. Summarizing, it can be stated that the multi-center clinical trial has shown very good results. For the new MIOL LENTIS Mplus, no complications were seen in both, unilateral and bilateral implantation. It can be centered stable in the capsular bag. As early as after three months, near and distance visual acuity are excellent; halo and glare effects are rarely reported. Particularly outstanding are the goods results achieved with regard to contrast perception which can be compared to this of a 20- year-old person with healthy eyes, plus the very high rate of patient satisfaction.