An interventional study of Juvene IOL and Tecnis® Monofocal (ZCB00, PCB00 or DCB00) in Cataract and Presbyopia, sponsored by LensGen, Inc.. Not yet recruiting. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by LensGen, Inc. · Not applicable, Interventional, and Treatment
To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 56 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →LensGen, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key 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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Juvene® IOL
Device: Juvene IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Cataract extraction and implantation of a posterior chamber IOL
Cataract extraction and implantation of a posterior chamber IOL
Distance-corrected intermediate ETDRS LogMar visual acuity
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Time frame: 12 Months
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Time frame: 12 Months
Defocus curve testing with ETDRS chart
Monocular diopters of depth of focus (DOF)
Time frame: 12 Months
Best corrected distance ETDRS LogMar visual acuity vs control
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Time frame: 12 Months
Best corrected distance ETDRS LogMar visual acuity
Monocular photopic best corrected distance visual acuity (BCDVA)
Time frame: 12 Months
Distance-corrected near ETDRS LogMar visual acuity
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Time frame: 12 Months
Distance-corrected near ETDRS LogMar visual acuity vs control
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
Time frame: 12 Months
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2023; primary completion for Nov 2024, 18 months later.
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 planned 18 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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LensGen, Inc.