An observational study in Posterior Capsule Opacification, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Observational
Investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing PCO
Cataract, the clouding of the eye's lens, is still the leading cause of blindness worldwide. Until now surgery is the only therapy available for the disease. Cataract surgery is nowadays considered a safe and efficient therapy. However, one of the most frequent complications of cataract surgery is posterior capsule opacification (PCO), which results in diminished postoperative visual acuity. PCO occurs due to a robust wound-healing response, where remaining lens epithelial cells in the capsular bag start to migrate and proliferate.
The lens capsule is divided into an anterior, an equatorial, and a posterior region. The anterior and the equatorial region consist of a single layer of cuboidal epithelial cells, whilst the posterior region is formed of fibers. In the adult lens proliferation occurs almost exclusively in the equatorial region and although the central part of the lens epithelium exhibits very low mitotic activity, it was shown in experiments that cell in this area are also stem cells. There are three possible reasons for the generation of PCO: intraoperative factors (dependening on the amount of remaining cells in the capsular bag), intraocular lens factors, and interpersonal factor (patient-specific factors).
Aim of this study is the generation of an in-vitro model of posterior capsule opacification. Therefore, the investigators will analyse the proliferative capacity of lens epithelial cells on the lens capsule, which is removed during cataract surgery, in a cell culture model. The investigators then compare the proliferative capacity between young and old patients, between both eyes of the same patient, and in different forms of cataract.
28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 11 observational studies indexed under Capsule Opacification.
Browse Capsule Opacification studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Patients undergoing cataract surgery
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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.
An in-vitro model is used to study lens epithelial cell proliferation
Procedure: In-vitro model
In-vitro model of posterior capsule opacification by culturing the lens capsule
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient
Proliferation of LECs in-vitro will be measured as area/mm2 and correlated with ratings of posterior capsular opacification in vivo using a scale from 0 to 10
Time frame: 24 months
Amount of proliferation of LECs in-vitro in young and older patients
Proliferation of LECs in-vitro will be measured as area/mm2 and compared between older and younger individuals
Time frame: 24 months
Amount of proliferation of LECs in-vitro between different forms of cataract
Proliferation of LECs in-vitro will be measured as area/mm2 and compared between the different forms of cataract (cortical, nuclear, posterior subcapsular)
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for May 2020, 16 months after the start.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Prim. Prof. Dr. Oliver Findl, MBA