1. 9-Month Results after Implantation of a new accommodative IOL that works with one focus Mark Tomalla M.D.* Clinic for Refractive and Ophthalmic Surgery, Clinic Niederrhein, Duisburg, Germany Boston, April 9-14, 2010 * The author has no financial interest in the subject matter of this poster

2. 9-Month Results after Implantation of the accommodative Crystalens HD The Crystalens HD (Bausch&Lomb GmbH, Berlin, Germany) is a novel accommodative IOL, which works with only one focus. It is a refractive IOL. In addition to cataract treatment, correction of myopia, hyperopia and mild astigmatism up to 0.75 can be performed. The IOL is thicker by 3 µm in the middle of the optic, so presbyopia correction is also achieved after surgery. The 5 mm optic consists of silicon material (RI = 1.427). The rigid haptics consist of polyimide. Diopter range: 10-35 dpt., between 18.0 and 22.0 in 0.25 increments. We are presenting the first 9-month results postoperative obtained within a prospective study. Purpose:

3. In a prospective, non-controlled, open observation study we treated thus far 74 eyes. 9-month results postoperative are presently available for 20 eyes. Postoperative examinations are performed immediately after surgery and after 1, 3, 6, 9 and 12 months. Visual acuity is examined with Jaeger charts (near vision), Sloan charts (intermediate vision) and Landolt rings (uncorrected distance vision). Patient satisfaction is investigated with a questionnaire. Methods: 9-Month Results after Implantation of the accommodative Crystalens HD

4. Surgery/Implantation differs clearly from a standard cataract surgery: The capsulorhexis must always be larger than the IOL optic (e.g. a 6 mm capsulorhexis is necessary for a 5 mm IOL optic). The anterior capsular bag must lie clearly outside the IOL optic. The IOL must be rotated until it fits exactly. Then the cortex and the viscoelastic substance behind the IOL optic must be carefully removed. Finally, the IOL must be pressed completely back onto the posterior capsular bag and may not move forward. Methods: 9-Month Results after Implantation of the accommodative Crystalens HD

5. Surgery/Implantation Video 9-Month Results after Implantation of the accommodative Crystalens HD

6. Directly postoperative The pupil is dilated immediately after surgery with 1 x Atropin. An accommodation block forms which lasts 10-14 days The haptics material polyimide causes the IOL to quickly grow together with the capsular bag by intentional fibrosis formation. The patient must not accommodate in the first 10 days after implantation, so this process can occur undisturbed and completely, During this phase, the patient experiences increased blinding sensitivity and cannot read. He must be made aware of this prior to surgery. Methods: 9-Month Results after Implantation of the accommodative Crystalens HD

7. Our experience has shown that optimal postoperative results are achieved after 4-6 weeks. Secondary cataract is treated early, 8-10 weeks after surgery. Specific YAG-capsulotomy is necessary: –a 3 mm central gap is realised –if astigmatism has been developed, ellipsoid 90º gaps should be created behind the optic-haptic-conjunctions in direction to the haptics. This reduces the tension that is exerted on the capsular bag and on the IOL. Advantages after YAG-capsulotomy: –It improves the mobility of the Crystalens HD. –It also offsets astigmatism which may have been induced. Methods: 9-Month Results after Implantation of the accommodative Crystalens HD

8. After 9 months: Binocular-operated patients showed considerably better values than monocular-operated. : UCVA for binocular patients (n=6) was: UCVA for binocular patients (n=6) was: Distance vision* 20/20 = 65%, 20/25 = 100%Distance vision* 20/20 = 65%, 20/25 = 100% Intermediate vision 20/20 = 100%Intermediate vision 20/20 = 100% Near vision 20/20 = 82 %, 20/30 = 100%Near vision 20/20 = 82 %, 20/30 = 100% UCVAwas: UCVA for monocular patients (n=14) was: Distance vision* 20/20 = 11%, 20/30 = 82%Distance vision* 20/20 = 11%, 20/30 = 82% Intermediate vision 20/20 = 100%Intermediate vision 20/20 = 100% Near vision 20/20 = 23%, 20/40 = 100%Near vision 20/20 = 23%, 20/40 = 100% Results: 9-Month Results after Implantation of the accommodative Crystalens HD *optimal biometry analysis was not available during our first implantations, therefore our first distance values are worse than average. This will be corrected when more cases can be analysed.

9. After 9 months postoperative 100% of the patients need no correction for distance vision. 100% of the patients show optimal intermediate vision. 71% of the patients no longer need reading glasses, 29% of the patients only occasionally need reading glasses. 100% of the operated patients had no blinding sensitivity or halos and unchanged night vision. Results: 9 9 -Month Results after Implantation of the accommodative Crystalens HD

10.  After implantation of the Crystalens HD, we achieved convincing postoperativeclinical results for both distance and near vision  The values in the intermediate range were particularly convincing  Most patients no longer or only occasionally need reading glasses after surgery  The principle of effect of this accommodative IOL, which works with only one focus, results in greater than average subjective patient satisfaction Conclusions: 9-Month Results after Implantation of the accommodative Crystalens HD