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Impressum
FDA Erbium Laser Phaco Study - prospective randomized multicentric determining of effectiveness and safety of PHACOLASE in cataract surgery
Höh H. Helmut Höh for the FDA Study Group,
Klinikum Neubrandenburg, Augenklinik
Background: In a pilot study, we could prove an endothelium protective
effect of ELP. To compare erbium laser phacoemulsification (ELP) to ultrasound
phacoemulsification (USP), a multicentric study of further findings takes
place in 6 study centers in California (2x), Oregon, Ohio, Florida and
Germany following a standardized protocol.
Methods: 150 eyes (115 post ELP, 35 post USP) were included into
the prospective randomized 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 centers. Eyes with nucleus hardnesses of grade 0 to 3 were included.
Excluding criteria were all vision threatening diseases. Following data
were noted down: usual data of patient, surgical technique and course,
corneal thickness, endothelial cell count, course of visual acuity 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, 74 patients are included into the study. Results
of 44 patients (21 female/23 male, age 39 - 84 years, 34 ELPs, 10 USPs)
are available. 3 months postoperatively, all eyes showed a visual acuity
of 0,4 and better. 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
USP patients, a posterior capsule fibrosis appeared. A cystoid macular
edema was not seen in any patient.
Conclusion: Based on these preliminary data, results after USP
and ELP are not different. At the congress, we will be able to present
the results of a higher number of patients.