An interventional study of IOL implantation experimental and IOL implantation active comparator in Cataract, Lens Opacities and Presbyopia, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Spain. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 14th 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: 50 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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 53 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.
This tab as a report to print or save as PDF → With an account.
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.
This tab as a report to print or save as PDF → With an account.
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
This is a prospective, randomised, 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. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.
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
hydrophilic, trifocal intraocular lens POD F
Device: IOL implantation active comparator
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Implantation of trifocal IOL POD F consisting of hydrophilic material
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Time frame: 3 months postoperative
Manifested refraction - Sphere
The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.
Time frame: 3 months postoperative
Manifested refraction - Cylinder
The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done 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 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 at 80cm (DCIVA)
DCIVA is measured with Radner reading charts placed in 80cm 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
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
DCIVA is measured with ETDRS charts placed in 63cm 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
Distance Corrected Near Visual Acuity at 40cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 40cm 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
Distance Corrected Near Visual Acuity at 25cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 25cm 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
Halometry
Halometry outcomes, measurement by halos software v1.0
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 - SA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration
Time frame: 3 months postoperative
Aberrometry - HOA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations
Time frame: 3 months postoperative
Aberrometry - Tilt
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt
Time frame: 3 months postoperative
OQAS II - OSI
Outcomes of OQAS II diagnostic device (Ocular Scatter Index)
Time frame: 3 months postoperative
OQAS II - MTF
Outcomes of OQAS II diagnostic device (Modular Transfer Function)
Time frame: 3 months postoperative
OQAS II - Strehl Ratio
Outcomes of OQAS II diagnostic device (Strehl Ratio)
Time frame: 3 months 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. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute
Time frame: 3 months postoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in May 2019, 19 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 19 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 May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beaver-Visitec International, Inc. →