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

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ClinicalTrials.gov Identifier: NCT03184428
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Posterior Capsule Opacification Other: Postoperative observation and survey

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.


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Study Type : Observational
Estimated Enrollment : 2775 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Implantation of IOL L313
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.
Other: Postoperative observation and survey
For postoperative Observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a YAG-Laser-Capsulotomy after Cataract-Surgery or not.




Primary Outcome Measures :
  1. Longterm rate of posterior capsule opacification following implantation of IOL 313 [ Time Frame: up to 8 years ]
    Evaluation of the Longterm rate of posterior capsule opacification following implantation of the IOL L313


Secondary Outcome Measures :
  1. Comparison to capsulotomy rates of other IOLs [ Time Frame: up to 8 years ]
    Comparison in the literature regarding to the Rate of posterior capsule opacification of other IOLs

  2. Correlations of capsulotomy rate to parameters [ Time Frame: up to 8 years ]

    Correlations of capsulotomy rate to the patient parameters:

    1. age
    2. gender,

      and to the 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
2775 (5564 eyes)
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 to much travel distance between study center and home

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184428


Contacts
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Contact: Ulrike Holland +49 395 77 53427 aug-st2@dbknb.de
Contact: Mandy Denkert +49 395 77 53425 aug-st1@dbknb.de

Locations
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Germany
Dietrich-Bonhoeffer-Klinikum Recruiting
Neubrandenburg, Mecklenburg/Vorpommern, Germany, 17036
Contact: Ulrike Holland    +49 395 775 3427    aug-st2@dbknb.de   
Contact: Mandy Denkert    +49 395 775 3425    aug-st1@dbknb.de   
Principal Investigator: Helmut Hoeh, MD         
Sub-Investigator: Christoforos Stylianides         
Sponsors and Collaborators
Dietrich-Bonhoeffer-Klinikum
Investigators
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Principal Investigator: Helmut Hoeh, Prof. Dr. Department of Ophthalmology, Neubrandenburg, Germany
Study Chair: Christoforos Stylianides Department of Ophthalmology, Neubrandenburg, Germany

Publications of Results:
Other Publications:

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Responsible Party: Dietrich-Bonhoeffer-Klinikum
ClinicalTrials.gov Identifier: NCT03184428     History of Changes
Other Study ID Numbers: STN 05/15
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: results will be published in ophthalmological journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dietrich-Bonhoeffer-Klinikum:
YAG-Laser Capsulotomy

Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Lens Diseases
Eye Diseases