Clinical trial NCT03184428: Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Capsule Opacification
Keywords: YAG-Laser Capsulotomy
Lead sponsor: Dietrich-Bonhoeffer-Klinikum
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 3785
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3785 (5549 eyes)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years
timeFrame: up to 8 years
Secondary outcomes:
measure: Correlation Coefficient Between Capsulotomy Rate and Parameters
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum
state: Mecklenburg/Vorpommern
Study officials:
affiliation: Department of Ophthalmology, Neubrandenburg, Germany
name: Helmut Hoeh, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Neubrandenburg, Germany
name: Christoforos Stylianides
role: STUDY_CHAIR
References:
citation: Apple DJ, Peng Q, Visessook N, Werner L, Pandey SK, Escobar-Gomez M, Ram J, Auffarth GU. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem. Ophthalmology. 2001 Mar;108(3):505-18. doi: 10.1016/s0161-6420(00)00589-3.
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