Guy Sallet
Aalst, Belgium
NCT Number: NCT04944238
The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)
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Notify Me50 year and older
All sexes
Observational
Aalst, Belgium
The study is a prospective series study with he principal objective to determine the IOL constant.
The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.
Time frame: 1-2 hours
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Time frame: 1 month
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Time frame: 3 months
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Time frame: 1-2 hours
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Time frame: 1 month
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Time frame: 3 months
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Beaver-Visitec International, Inc.
Industry
Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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