An interventional study of IOL implantation experimental (Isopure 1.2.3.) in Cataract and Lens Opacities, sponsored by Beaver-Visitec International, Inc.. Completed at 6 sites in Spain. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The study will be carried out in up to five clinical centers in Spain. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic Premium Monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv.
Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically.
The primary performance endpoint is to show that the monocular Best Corrected Distance Visual Acuity (CDVA) measured in the study group is statistically non-inferior to outcomes of the monofocal parent lens Micropure 1.2.3. The comparative data is used from the latest Clinical Evaluation Report (CER) for the monofocal Micropure 1.2.3. lens. To avoid bias, only the first implanted eye will be considered for this calculation. Data interim analyses will be done after the last patient finished the 1 study visit postoperative examination to support the study publication plan.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 109 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Experimental arm: Premium Monofocal intraocular lens.
Device: IOL implantation experimental (Isopure 1.2.3.)
Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p \< 0.025) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
Time frame: From 120 days postoperative
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Beaver-Visitec International, Inc.