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Evaluation of the performance and the stability of an intraocular lens.


- candidate number11030
- NTR NumberNTR3261
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2012
- Secondary IDs 
- Public TitleEvaluation of the performance and the stability of an intraocular lens.
- Scientific TitleEvaluation of the performance and the stability of an intraocular lens.
- ACRONYMC-Loop glistening free IOL
- hypothesisA new generation hydrophobic acrylic polymer, the GF® raw material (Physiol) equilibrated in saline solution prior to implantation combines the benefits of two families of IOL materials, i.e., hydrophobic and hydrophilic acrylic materials (glistening free, bioadhesion, rapid unfolding after injection).
- Healt Condition(s) or Problem(s) studiedGlistening in hydrophobic biomaterial, Bioadhesion, Biocompatibility, Posterior Capsule Opacification, Intraocular lens stability
- Inclusion criteriaPatients requiring a cataract surgery.
- Exclusion criteria1. Younger than 21 years old;
2. Informed consent not signed.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2012
- planned closingdate
- Target number of participants50
- Interventions1. Standard cataract surgery;
2. Standard follow-up (slit lamp examination, clinical outcomes, visual acuity testing).
- Primary outcome1. Glistening evaluation;
2. PCO rate;
3. IOL stability.
- Secondary outcome1. No adverse events;
2. Surgical facility.
- Timepoints0 day, 1 day, 1 week, 3-5 week, 4 months, 1 year.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P. Sempoux
- CONTACT for SCIENTIFIC QUERIESDr. P. Sempoux
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Physiol s.a.
- PublicationsN/A
- Brief summaryThe purpose of the trial is to survey the in-vivo behavior of an IOL with a new material with a classical C-loop design. It wants to demonstrate the absence of glistening and a cell adhesion similar to the one demonstrated in vitro. The IOL stability after implantation is going to be investigated.
- Main changes (audit trail)
- RECORD26-jan-2012 - 7-feb-2012


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