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A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

RecruitingNAAges 21 Years - anyAllBiotech Healthcare Holding Gmbh
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In plain words

What the trial is, and whether it could suit you

Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients 21 years old or older. * Calculated IOL Power is within the range of the investigational IOLs * Corneal Cylindrical error within the range defined in the clinical investigation plan * Subject has monocular UCVA 0.5 LogMAR or worse * Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history. * Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria: 1. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction. 2. Two refractions were performed at least 7 days apart. * Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction. * Expected dilated pupil size at least large enough to visualize the axis marking. * Patients willing to attend all follow-up appointments * Patients must sign and be given a copy of the written Informed Consent form Exclusion Criteria: * Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation. * Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject * Subject with ocular condition that may predispose the subject to future complications * Subject with previous intraocular or corneal surgery * Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment * Pregnant or planning to become pregnant, or is lactating during the course of the evaluation * Other condition associated with fluctuation of hormones * ACD measured from the endothelium lower than 2.8 mm * Concurrent participation in another drug or device evaluation. * Any cataract of any grade. * Coefficient of variation of endothelial cell area \>0.45 * Percent Hexagonality of endothelial cell shape ≤ 45% * Monocular subject * Vulnerable subjects as defined in section 12.3.10
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What it tests

  • EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm
  • Visian® Toric ICL Treatment Arm
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Where

4 sites
Precise Vision Augentagesklinik Greven
Münster, Germany
Precise Vision Augentagesklinik Rheine
Rheine, Germany
Precise Vision Augentagesklinik Rheine
Steinfurt, Germany
Netradhama Superspeciality Eye Hospital
Bangalore, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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