An interventional study of IOL implantation in Cataract and Lens Opacities, sponsored by Beaver-Visitec International, Inc.. Completed at 2 sites in Italy. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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Among 36 studies in Cataract by Beaver-Visitec International, Inc. — none open to participants now, 2 under way, none of them phase 3. Cataract · Beaver-Visitec International, Inc..
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., this one is the 5th largest by enrollment of the 28 interventional ones that give a count, is one of 6 that started in 2017, is one of 28 with no phase, and was the 5th registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 36 studies in Cataract by Beaver-Visitec International, Inc. is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 6 started in 2017.
This study's enrollment of 121 is above the median of 79 across 1,094 interventional studies indexed under Cataract.
Median enrollment 53 across the 28 interventional studies, 62 across the 8 observational. Of the 32 that completed or were terminated, 2 (6%) have results posted.
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Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.
Follow up will be up to 24 months postoperative.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of Micropure 1.2.3. in one of the eyes of the study subject
Device: IOL implantation
Implantation of monofocal IOL Micropure 1.2.3
monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).
Time frame: 6 months postoperative
Posterior capsule opacification (PCO) grading
grade of the PCO determined by slitlamp
Time frame: 2 years postoperative
Uncorrected Distance Visual acuity (UDVA)
Monocular Uncorrected Distance Visual acuity (UDVA)
Time frame: 6 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Time frame: 6 months postoperative
Glistening assessment
Assessment of glistenings by slitlamp determination
Time frame: 2 years postoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Sep 2022, 58 months.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 58 months is above that.
Counting every sponsor, half of 493 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Beaver-Visitec International, Inc. →