Aktuelle Tagungsinformationen
News and Updates
Anmeldung zur Tagung
Registration
Hotelbuchung
Hotel Registration
Grußwort
Welcome address
Beteiligte Gesellschaften
Societies involved
Eröffnung des Kongresses
Opening Ceremony
Preise
Awards
Wissenschaftliches Programm
Scientific program
Posterpräsentationen
Poster Presentation
Kurse
Courses
Begleitende Veranstaltungen
Collateral Events
Rahmenprogramm
Social program
Jubiläumsparty
Jubilee Party
DOG Information
DOG Information
Allgemeine Informationen
General Information
Autorenindex
Index of Authors
Ausstellerliste
Exhibitors
Sponsoren
Sponsors
Teilnahmegebühren
Registration fees
Impressum
DOG Homepage
USA-FDA Erbium Laser Phaco Study - Prospective Randomized Multi-centric Assessment of Effectiveness and Safety of PHACOLASE in Cataract Surgery
1Höh H., 2FDA-Studiengruppe ,
1Klinikum Neubrandenburg, Klinik für Augenheilkunde (Neubrandenburg)
2 (Neubrandenburg)
Purpose: In a pilot study and in the first clinical tests, we found an endothelium protective effect of the erbium laser phacoemulsification (ELP) in comparison to a historical ultrasonic group. For the admission by the USA FDA, a multicentric study in 7 study sites (California (2x), Oregon, Ohio, Florida, Minnesota and Germany) was initiated by Asclepion-Meditec Co., Jena, Germany, following a standardized protocol. We report our results.
Method: 150 eyes (115 for ELP, 35 for USP) were included into the prospective ran-domized comparative study following the FDA protocol. ELP was carried out by PHACOLASE (Asclepion Meditec Co., Jena, Germany). USP was carried out by those ultrasonic phaco machines, which were available in the different study sites. Eyes with nucleus hardnesses of grade 0 to 3 were included. Excluding criteria were all vision threatening diseases. The following data were evaluated: personal data of patient, surgical technique and postoperative course, visual acuity, intraocular pressure, corneal thickness, endothelial cell count and complications. Examination took place preoperatively and 1 day, 1 week, 1 and 3 months postoperatively. In case of existing macula edema in the 3-month examination, further examinations were done 4, 5 and 6 months postoperatively.
Results: Until now, 150 eyes are included into the study. Results of 113 eyes (47 % female/53 % male, age 39 - 84 years, 89 ELPs, 24 USPs) are available. Efficacy of ELP is 98.5 %. 3 months postoperatively, all eyes showed a visual acuity of 0,4 and better. Central corneal thickness increased after USP by +1.6 %, where it is decreased after ELP by -0.1 %. Endothelial cell loss was 1.9 % in the ELP group and 1.7 % in the USP group. One ELP patient showed a posterior capsule rupture; this occurred during the first ELP in one study center. In one of the ELP patients, a posterior capsule fibrosis appeared. A cystoid macular edema was not seen in any patient.
Conclusions: Based on these preliminary data, efficacy and safety of ELP is high. The results after USP and ELP are not statistically significantly different. At the time of the convention, we will be able to present the final results of the study including all 150 eyes.