An observational study in Posterior Capsule Opacification, sponsored by Dietrich-Bonhoeffer-Klinikum. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2020-04-29.
Sponsored by Dietrich-Bonhoeffer-Klinikum · Observational
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.
28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.
This study's enrollment of 3,785 is above the median of 200 across 11 observational studies indexed under Capsule Opacification.
Browse Capsule Opacification studies →Dietrich-Bonhoeffer-Klinikum is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
3785 (5549 eyes)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 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).
Time frame: up to 8 years
Correlation Coefficient Between Capsulotomy Rate and Parameters
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.
Time frame: up to 8 years
Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens implanted.
| Milestone | L313-Implantation |
|---|---|
| Started | 3785 |
| Completed | 2963 |
| Not completed | 822 |
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).
| percentage of eyes | Implantation of IOL L313 Age<55 | Implantation of IOL L313 Age≥55 |
|---|---|---|
| 1 year | 7.9 | 4.7 |
| 2 years | 17.1 | 8.2 |
| after 4 years | 25.0 | 17.2 |
| after 6 years | 25.6 | 22.4 |
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.
| Correlation coefficient | Capsulotomy Rate/Age | Capsulotomy Rate/Gender | Capsulotomy Rate/Cutting Lenth | Capsulotomy Rate/Core Hardness | Capsulotomy Rate/Duration of Whole Operation | Capsulotomy Rate/Time of Phaco-emulsification | Capsulotomy Rate/Phaco-energy | Capsulotomy Rate/Phaco-machine | Capsulotomy Rate/Combination With Other op | Capsulotomy Rate/Surgeon | Correlation Rate/Power of IOL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.0001 | 0.276 | 0.578 | 0.041 | 0.467 | 0.739 | 0.782 | 0.746 | 0.002 | 0.727 | 0.578 |
Collected over n/a All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because no interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implantation of IOL L313 | — | — | — |
| Age, Categorical(eyes) | Implantation of IOL L313 |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 886 |
| >=65 years | 4661 |
| Age, Continuous(years) | Implantation of IOL L313 |
|---|---|
| Mean | 73.75 ± 9.06 |
| Sex: Female, Male(eyes) | Implantation of IOL L313 |
|---|---|
| Female | 3285 |
| Male | 2264 |
| Race and Ethnicity Not Collected(Participants) | Implantation of IOL L313 |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — results will be published in ophthalmological journals
Ran from Oct 2015 to primary completion in Mar 2018, 29 months.
Results were first posted in Apr 2020, 2 years 1 month after primary completion.
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Dietrich-Bonhoeffer-Klinikum