Eligibility, any sex, with Posterior Capsule Opacification. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 YearsPrimary· 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 c
1 year
Group
Value
95% CI
Implantation of IOL L313 Age<55
7.9
Implantation of IOL L313 Age≥55
4.7
2 years
Group
Value
95% CI
Implantation of IOL L313 Age<55
17.1
Implantation of IOL L313 Age≥55
8.2
after 4 years
Group
Value
95% CI
Implantation of IOL L313 Age<55
25.0
Implantation of IOL L313 Age≥55
17.2
after 6 years
Group
Value
95% CI
Implantation of IOL L313 Age<55
25.6
Implantation of IOL L313 Age≥55
22.4
Correlation Coefficient Between Capsulotomy Rate and ParametersSecondary· 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.
Group
Value
95% CI
Capsulotomy Rate/Age
0.0001
Capsulotomy Rate/Gender
0.276
Capsulotomy Rate/Cutting Lenth
0.578
Capsulotomy Rate/Core Hardness
0.041
Capsulotomy Rate/Duration of Whole Operation
0.467
Capsulotomy Rate/Time of Phaco-emulsification
0.739
Capsulotomy Rate/Phaco-energy
0.782
Capsulotomy Rate/Phaco-machine
0.746
Capsulotomy Rate/Combination With Other op
0.002
Capsulotomy Rate/Surgeon
0.727
Correlation Rate/Power of IOL
0.578
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dietrich-Bonhoeffer-Klinikum
Last refreshed: 29 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03184428.