An observational study in Cataract, Vitrectomy and Vitrectomy Operation Under General Anesthesia, sponsored by Beaver-Visitec International, Inc.. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Beaver-Visitec International, Inc. · Observational
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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 only one that started in 2025, is one of 8 observational ones, and was the 36th 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: 18 Years and older · all sexes · no healthy volunteers.
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. 1 started in 2025.
This study's planned enrollment of 205 is above the median of 89 across 475 observational 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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This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
The Virtuoso® DUAL Advanced Vision Solutions system is a multifunctional phacoemulsification-vitrectomy system consisting of equipment and accessories for use in ophthalmic surgeries. The system is indicated for both anterior segment (i.e. phaco-emulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In this study, the system is used within its intended purpose. Study participants will undergo a routine vitrectomy procedure, cataract procedure or combined procedure, depending on their medical needs, using the investigational phaco-vitrectomy system. Data will be collected on the use and functioning of the device, the ability to complete procedures with the device according to the standard of care, and clinical safety and performance outcomes.
Patient scheduled for either cataract surgery (subgroup "cataract"), pars-plana vitrectomy surgery, regardless of the indication (subgroup "vitrectomy"), or vitrectomy combined with cataract surgery (subgroup "combined procedure")
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients recruited in this subgroup will undergo their routine cataract surgery. The Vitrectomy device will be used during surgery during the phacoemulsification phase of the surgery.
The patients in this group will undergo the pars-plana vitrectomy surgery prescribed by their eye doctor. The device will be used to remove the vitreous humor and/or scar tissue which affect the retina.
The patients included in this group will undergo combined surgery as recommended by their eye doctor. The device will be used for the phacoemulsification and pars-plana vitrectomy phases of the surgery.
The primary endpoint is to confirm the non-inferiority of the rate of specific intraoperative adverse events compared to the rates reported in the literature.
Objective: The hypothesis being tested in this non-inferiority study of the Virtuoso aims to demonstrate that the safety of this device, in terms of intraoperative surgical adverse event rates, is not significantly worse than the rates already established in the literature for similar devices or surgical techniques. Specifically, the study seeks to prove that the Virtuoso device's safety remains within a clinically acceptable margin of non-inferiority when compared to the adverse event rates observed with comparable phaco-vitrectomy systems.
Time frame: During surgery (intraoperative)
Ability to complete the procedure as planned, using the device
The co-primary endpoint is to confirm the non-inferiority of the ability to complete the procedure as planned using the device compared to rates reported in the literature. The ability to complete the procedure as planned will be defined as the percentage of procedures successfully completed without specific device deficiencies (numerator) divided by the total number of procedures performed (denominator). This rate will be expressed as a percentage (%) and analysed for non-inferiority relative to published data.
Time frame: During surgery
Rate of postoperative Adverse Events (AEs)
The rate of Adverse Events (AEs) intra-operatively, defined as the percentage of procedures with at least one identified AE (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
To evaluate the performance of the device
Rate of Device Deficiencies (DDs) intra-operatively: The rate of Device Deficiencies (DDs) intra-operatively, defined as the percentage of procedures with at least one identified device deficiency (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Time frame: During surgery (intraoperative)
To evaluate the possible reduction of total surgical time
Collection of procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless procedure
\- Rate of sutureless cataract procedure (cataract and combined subgroups)
Time frame: During surgery (intraoperative)
To obtain data on the use of other CE-marked BVI products used during the surgery, including silicone oils, perfluorocarbon liquids (PFCLs) and gases
* Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge * List of all other medical devices used during the procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - success rate
\- Success rate of intended surgical procedures
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - procedure time
\- Procedure time(s) for subgroups cataract, vitrectomy and combined procedure)
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - fluid volume
\- Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure)
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- List of all other medical devices used during the procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - Aspiration
\- Evaluation of the learning curve for surgeons using the new system: ADE and Aspiration time, Total Procedure Time for subgroups cataract, vitrectomy and combined procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless vitrectomy
\- Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):
Time frame: During surgery (intraoperative)
Anatomical success (for subgroups vitrectomy and combined procedure):
Achievement of intended anatomical outcomes, such as retinal reattachment expressed as the number of successful procedures (numerator) out of the total performed (denominator), measured as percentage (%)
Time frame: From surgery until end of treatment at 90 days
Manifest refraction and BCDVA (sphere and cylinder) (for subgroups cataract, vitrectomy and combined procedure):
Mean monocular distance contrast sensitivity (photopic with and without glare, measured at 4m) at 1 day (visit 1) and 90 days (Visit 3)
Time frame: At 1 day (Visit 1) and at 90 days (Visit 3)
Corneal oedema grading (by slit lamp examination) (for subgroups cataract and combined procedure)
Graded on a standardized scale (e.g., 0 = none, 1 = mild, 2 = moderate, 3 = severe) using slit lamp biomicroscopy.
Time frame: from enrollment until end of treatment at 90 days
Central macular thickness (for subgroups cataract, vitrectomy and combined procedure: within vitrectomy and combined subgroups, group data by Gauge)
Central macular thickness (CMT) measured by OCT in microns.
Time frame: from enrollment until end of treatment at 90 days
Endothelial cell count (ECC)
Defined as the mean change in cell density from baseline to Visit 2, measured in cells per square millimeter (cells/mm²), for subgroups undergoing cataract surgery and combined procedures.
Time frame: from enrollment until end of treatment at 90 days
Endothelial cell density: (for subgroup cataract):
Comparison between pre-op examination and Visit 3 examination.: Endothelial cell density expressed as cells/mm².
Time frame: from enrollment until end of treatment at 90 days
Description of wound architecture before IOL implantation from intra-op OCT (for subgroups cataract and combined)
Qualitative OCT imaging of corneal or scleral wound architecture before intraocular lens (IOL) implantation.
Time frame: from enrollment until end of treatment at 90 days
Description of sclerotomy wound closure Visit 1 and Visit 3 post-op (OCT images, vitrectomy and combined sub-groups by Gauge)
Qualitative evaluation of sclerotomy closure at Visit 1 and Visit 3 post-op using OCT, grouped by gauge size
Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
Fundus examination
Any abnormalities or observations noted during a detailed fundus examination post-operatively
Time frame: from enrollment until end of treatment at 90 days
Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):
Surgeries where pars plana vitrectomy was completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.
Time frame: During surgery (intraoperative)
Rate of sutureless cataract procedure (cataract and combined subgroups):
Definition: Cataract surgeries completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.
Time frame: During surgery (intraoperative)
Success rate of intended surgical procedures (complete cataract removal, successful retinal re-attachment and macular hole closure by Gauge):
Numerator: Successfull procedures. Denominator: Total procedures in performed.
Time frame: During surgery (intraoperative)
Procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
* Set-up time * Total Aspiration time (GUI) * Phacoemulsification time (cataract and combined subgroups only) (intended as time in P3, from GUI) * Total Procedure Time : to be associated with gauge size and cataract hardness. Time measurements for total procedure steps measured in seconds
Time frame: During surgery (intraoperative)
Fluid volume used for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
(measured in ml) * Total Irrigation fluid (GUI) * Total aspiration fluid (GUI)
Time frame: During surgery (intraoperative)
List of all other medical devices used during the procedure
List of all other medical devices used during the procedure * System components and accessories * Cannula gauge size * Arcadophta products
Time frame: During surgery (intraoperative)
Learning curve
Evaluation of the learning curve for surgeons using the new system: ADE and Aspiration time, Total Procedure Time for subgroups cataract, vitrectomy and combined procedure
Time frame: During surgery (intraoperative)
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Oct 2026, 10 months after the start.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 10 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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