Posterior Capsule Opacification Clinical Trial
Official title:
Retro- and Prospective Monocentric Study to Evaluate the Rate of Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS (Micro Incision Cataract Surgery) -IOL (Intraocular Lens) L313
This study collects intra- and postoperative data from the patients´charts retrospectively and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO) following implantation of the intraocular lens L 313.
This study is a postmarket study without interventions. Within the Standard Care Cataract
surgery the participants have been implanted with the intraocular lens L313 in the period
between September 2009 and December 2013. As criterium for the PCO was considered the Nd:YAG
capsulotomy.
In the first step of the study, data was collected from the patients´charts.
In the second phase, a questionaire was sent to the patients with no recent examination,
asking them to answer whether or not participants received a laser procedure due to PCO. In
doubt the participants could answer: "I am not certain". For this step the investigator
ensured the positive Votum of the Ethic Committee of the University of Greifswald, Germany.
On the third step of the study, the patients that were not certain of having such a laser
procedure or did not answer per post, will be contacted on telephone. By uncertainty or no
answer on the telephone the family eye doctor will be contacted to receive the necessary
information. If the eye doctor has lost contact to the patient, then this patient will be
documented as lost-to-follow-up.
Excluded were the patients that live >50km from the Department of Ophthalmology in
Neubrandenburg, as well as patients with intraoperative capsule tear.
For the statistical analysis was used the program STATISTICA (StatSoft, Hamburg, Germany) and
the survival analysis using the Kaplan-Meier formula, the statistical significance using the
Chi-squared test and Spearman-Rank corelation and the Bonferroni adjustment if the test was
repeated.
The investigators compared these results with the results of other publication. In order to
do that the investigators calculated the capsulotomy quote from this study according to the
time of the PCO recorded on the other studies. Included were only comparing studies that also
used YAG-capsulotomy as criterium for the PCO.
Furthermore secondary data was collected: age, gender, cutting length, core hardness,
duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine,
combination with other operation, surgeon, power of IOL. This data will be taken in concern
for the validity of this study.
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