Posterior Capsule Opacification
Conditions
Keywords
YAG-Laser Capsulotomy
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.
Interventions
OTHERPostoperative 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.
Sponsors
Dietrich-Bonhoeffer-Klinikum
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
The following reasons led to an exclusion of participants: * intraoperative posterior capsule rupture * Distance between place of residence and place of investigation \>50 km * Exchange of the intraocular lens * Practice closure of the supervising ophthalmologist * no entry in any established doctor's medical system * no follow-up
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 Nd: YAG-Laser-Capsulotomy after Cataract-Surgery or not. | 3,785 |
| 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.
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 Nd: YAG-Laser-Capsulotomy after Cataract-Surgery or not. | 5,549 |
| Total | 9,334 |
Baseline characteristics
| Characteristic | Implantation of IOL L313 |
|---|---|
| Age, Categorical <=18 years | 2 eyes |
| Age, Categorical >=65 years | 4661 eyes |
| Age, Categorical Between 18 and 65 years | 886 eyes |
| Age, Continuous | 73.75 years STANDARD_DEVIATION 9.06 |
| Sex: Female, Male Female | 3285 eyes |
| Sex: Female, Male Male | 2264 eyes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implantation of IOL L313 Age<55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | after 6 years | 25.6 percentage of eyes |
| Implantation of IOL L313 Age<55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | 1 year | 7.9 percentage of eyes |
| Implantation of IOL L313 Age<55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | 2 years | 17.1 percentage of eyes |
| Implantation of IOL L313 Age<55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | after 4 years | 25.0 percentage of eyes |
| Implantation of IOL L313 Age≥55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | after 4 years | 17.2 percentage of eyes |
| Implantation of IOL L313 Age≥55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | after 6 years | 22.4 percentage of eyes |
| Implantation of IOL L313 Age≥55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | 2 years | 8.2 percentage of eyes |
| Implantation of IOL L313 Age≥55 | Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years | 1 year | 4.7 percentage of eyes |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implantation of IOL L313 Age<55 | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.0001 Correlation coefficient |
| Implantation of IOL L313 Age≥55 | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.276 Correlation coefficient |
| Capsulotomy Rate/Cutting Lenth | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.578 Correlation coefficient |
| Capsulotomy Rate/Core Hardness | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.041 Correlation coefficient |
| Capsulotomy Rate/Duration of Whole Operation | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.467 Correlation coefficient |
| Capsulotomy Rate/Time of Phaco-emulsification | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.739 Correlation coefficient |
| Capsulotomy Rate/Phaco-energy | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.782 Correlation coefficient |
| Capsulotomy Rate/Phaco-machine | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.746 Correlation coefficient |
| Capsulotomy Rate/Combination With Other op | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.002 Correlation coefficient |
| Capsulotomy Rate/Surgeon | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.727 Correlation coefficient |
| Correlation Rate/Power of IOL | Correlation Coefficient Between Capsulotomy Rate and Parameters | 0.578 Correlation coefficient |
p-value: <0.05Spearman's rank-order correlation