An interventional study of IOL implantation experimental in Cataract, Lens Opacities and Presbyopia, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in France. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
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 20th largest by enrollment of the 28 interventional ones that give a count, is one of 5 that started in 2018, is one of 28 with no phase, and was the 7th registered.
1,630 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 · healthy volunteers too.
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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. 5 started in 2018.
This study's enrollment of 25 is below 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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Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)
This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium).
The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.
The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens.
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
hydrophobic, trifocal intraocular lens POD F GF
Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
binocular Uncorrected Distance Visual Acuity (UDVA)
Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Time frame: 3 months postoperative
Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Time frame: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA)
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Corrected Distance Visual Acuity (CDVA)
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Distance Corrected Intermediate Visual Acuity (DCIVA)
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Uncorrected Intermediate Visual Acuity (UIVA)
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Distance Corrected Near Visual Acuity (DCNVA)
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Uncorrected Near Visual Acuity (UNVA)
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 3 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Time frame: 3 months postoperative
Aberrometry
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
Time frame: 3 months postoperative
PCO rate
The rate of patients showing posterior capsular opacities (PCO) long term after surgery will be assessed. The criteria is, if the eye requires a secondary treatment to remove the PCO.
Time frame: 2 years postoperative
questionnaire
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100.
Time frame: 3 months postoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Nov 2020, 33 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 33 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 Jan 2022. You cannot join it, but the record below documents what was studied.
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Beaver-Visitec International, Inc. →