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

Sponsor
Dietrich-Bonhoeffer-Klinikum (Industry)
Overall Status
Completed
CT.gov ID
NCT03184428
Collaborator
(none)
3,785
Enrollment
1
Location
38.3
Actual Duration (Months)
98.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
3785 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 :
Oct 1, 2015
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Dec 10, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Correlation Coefficient Between Capsulotomy Rate and Parameters [up to 8 years]

    Correlation coefficients between capsulotomy rate and patient parameters: age gender, and surgical parameters: cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of IOL.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dietrich-Bonhoeffer-Klinikum Neubrandenburg Mecklenburg/Vorpommern Germany 17036

Sponsors and Collaborators

  • Dietrich-Bonhoeffer-Klinikum

Investigators

  • Principal Investigator: Helmut Hoeh, Prof. Dr., Department of Ophthalmology, Neubrandenburg, Germany
  • Study Chair: Christoforos Stylianides, Department of Ophthalmology, Neubrandenburg, Germany

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Dietrich-Bonhoeffer-Klinikum
ClinicalTrials.gov Identifier:
NCT03184428
Other Study ID Numbers:
  • STN 05/15
First Posted:
Jun 12, 2017
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Cataract
Capsule Opacification

Study Results

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 Detail 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
Arm/Group Title L313-Implantation
Arm/Group Description 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.
Period Title: Overall Study
STARTED 3785
COMPLETED 2963
NOT COMPLETED 822

Baseline Characteristics

Arm/Group Title Implantation of IOL L313
Arm/Group Description 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.
Overall Participants 3785
Overall eyes 5549
Age (eyes) [Count of Units]
<=18 years
2
Between 18 and 65 years
886
>=65 years
4661
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
73.75
(9.06)
Sex: Female, Male (eyes) [Count of Units]
Female
3285
Male
2264
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Implantation of IOL L313 Age<55 Implantation of IOL L313 Age≥55
Arm/Group Description Patients age<55 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. Patients age≥55 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.
Measure Participants 111 2852
Measure eyes 164 4224
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
2. Secondary Outcome
Title Correlation Coefficient Between Capsulotomy Rate and Parameters
Description Correlation coefficients between capsulotomy rate and patient parameters: age gender, and surgical parameters: cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of IOL.
Time Frame up to 8 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title 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
Arm/Group Description Correlation coefficient between capsulotomy rate and age Correlation coefficient between capsulotomy rate and gender Correlation coefficient between capsulotomy rate and cutting length Correlation coefficient between capsulotomy rate and core hardness Correlation coefficient between capsulotomy rate and duration of whole operation Correlation coefficient between capsulotomy rate and time of phaco-emulsification Correlation coefficient between capsulotomy rate and phaco-energy Correlation coefficient between capsulotomy rate and phaco-machine Correlation coefficient between capsulotomy rate and L-313 implantation in combination with other op Correlation coefficient between capsulotomy rate and surgeon Correlation coefficient between capsulotomy rate and power of IOL
Measure Participants 2963 2852 2852 2929 3036 3017 2857 2990 2852 3784 2852
Measure eyes 4388 4224 4224 3944 4068 4088 3864 3906 4224 4049 4224
Number [Correlation coefficient]
0.0001
0.276
0.578
0.041
0.467
0.739
0.782
0.746
0.002
0.727
0.578
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Implantation of IOL L313 Age<55, Implantation of IOL L313 Age≥55, 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
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Spearman's rank-order correlation
Comments Bonferroni adjustment in addition

Adverse Events

Time Frame 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).
Adverse Event Reporting Description No interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required), thus adverse events were not monitored (including Serious Adverse Events, All-Cause-Mortality, Other Adverse Events). An investigation would have been necessary only in case of low patient's response.
Arm/Group Title Implantation of IOL L313
Arm/Group Description 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.
All Cause Mortality
Implantation of IOL L313
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Serious Adverse Events
Implantation of IOL L313
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Implantation of IOL L313
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Christoforos Stylianides
Organization Eyestylianides ophthalmology center
Phone 0035725320244
Email Info@eyestylianides.com
Responsible Party:
Dietrich-Bonhoeffer-Klinikum
ClinicalTrials.gov Identifier:
NCT03184428
Other Study ID Numbers:
  • STN 05/15
First Posted:
Jun 12, 2017
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020