Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313

Completed

Conditions: Posterior Capsule Opacification

Interventions: Other: Postoperative observation and survey

Registration Number: NCT03184428

Lead Sponsor: Dietrich-Bonhoeffer-Klinikum

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3785

Inclusion Criteria

retrospective: Patients who have undergone a Cataract surgery with Implantation of IOL L313
prospective: signed informed consent

Exclusion Criteria

capsule rupture
patients with too much travel distance between study center and home

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implantation of IOL L313	Postoperative observation and survey	Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years	up to 8 years	In order to find out whether patients with cataract surgery are affected by lens opacification, we assessed whether a Nd:YAG laser capsulotomy was performed for treatment. For this purpose, the patient files were spotted first. Those who had no recent findings were asked in writing if and when a laser treatment was performed. In the absence of feedback and in case of uncertain or unusable written answer, a telephone consultation with the patient was made. If sufficient information was not available afterwards, the ophthalmologist was asked for information (by phone, by written request or by collecting the data on site in the practices).

Secondary Outcome Measures

Name	Time	Method
Correlation Coefficient Between Capsulotomy Rate and Parameters	up to 8 years	Correlation coefficients between capsulotomy rate and patient parameters: 1. age 2. gender, and surgical parameters: 3. cutting length, 4. core hardness, 5. duration of whole operation, 6. time of phaco-emulsification, 7. phaco-energy, 8. phaco-machine, 9. combination with other operation, 10. surgeon, 11. power of IOL.