An interventional study of Capsular polishing and Non capsular polishing 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 · Not applicable, Interventional, and Prevention
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification
Cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. Cataract surgery is nowadays considered a safe and efficient procedure. However, one of the most frequent complications after surgery is posterior capsule opacification (PCO), that results in diminished postoperative visual acuity. PCO occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate.
PCO can be easily treated by performing a neodymium-doped yttrium aluminium garnet (Nd-YAG) laser capsulotomy. However, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. Furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia.
Therefore, it would be necessery to identify different approaches to prevent generation of PCO. One approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. Hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of LECs.
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 63 across 16 interventional 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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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.
No capsular polishing taking place during cataract surgery
Other: Non capsular polishing
Capsular polishing taking place during cataract surgery
Procedure: Capsular polishing
Capsular polishing taking place during cataract surgery
No capsular polishing taking place during cataract surgery
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
Posterior capsule opacification will be graded using a score from 0 (clear capsule) to 10 (very severe PCO)
Time frame: 6 months
Difference in the number of cells in the anterior chamber between the eye with capsular polishing and the eye without capsular polishing in the same patient
Number of cells in the anterior chamber will be rated using a laser flare meter
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2019 (actual). Primary completion is estimated for May 2020, 14 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