N/A
N=3,785
Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313
Posterior Capsule Opacification
Bottom Line
View on ClinicalTrials.gov: NCT03184428 ↗Enrolled (actual)
3,785
Serious AEs
—
Results posted
Apr 2020
Primary outcome: Primary: Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years — 7.9; 4.7; 17.1; 8.2 percentage of eyes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Postoperative observation and survey (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dietrich-Bonhoeffer-Klinikum
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years |
7.9; 4.7; 17.1; 8.2; 25.0; 17.2 | — |
| SECONDARY Correlation Coefficient Between Capsulotomy Rate and Parameters |
0.0001; 0.276; 0.578; 0.041; 0.467; 0.739 | <0.05 sig |
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.
Eligibility 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 too much travel distance between study center and home
Data sourced from ClinicalTrials.gov (NCT03184428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.