Clinical trial NCT06799156: Clinical Study to Investigate the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
Official title: Clinical Study to Investigate the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Vitrectomy
Vitrectomy Operation Under General Anesthesia
Keywords: vitrectomy device
vitrectomy
vitrectomy surgery
cataract surgery
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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")

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary or repeat vitrectomy (only applicable to patients scheduled for vitrectomy or combined procedure)
* Patients aged ≥ 18 years
* Willing and able to provide written informed consent for participation in the study
* Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* Patients aged \< 18 years
* No post-operative 90 days visit is anticipated
* Patients requiring or having already had scleral buckling
* Patients with ocular comorbidities affecting surgical view including corneal opacities or scar
* Pre-operative endothelial cell count \<1500 cells/cm2 (only applicable to patients considered for the cataract subgroup or the combined surgeries subgroup)
* Advanced and secondary glaucoma
* History of intraocular inflammation
* Untreated diabetes
* Microphthalmos or macrophthalmos
* Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
* Post-Traumatic eye
* Subluxated lens
* Morganian cataract
* Weak zonules: zonuli lysis or zonula laxa manifest
* Pregnant or nursing females

Primary outcomes:
measure: 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.
timeFrame: During surgery (intraoperative)
measure: Ability to complete the procedure as planned, using the device
timeFrame: During surgery
Secondary outcomes:
measure: Rate of postoperative Adverse Events (AEs)
timeFrame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
measure: To evaluate the performance of the device
timeFrame: During surgery (intraoperative)
measure: To evaluate the possible reduction of total surgical time
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To obtain data on the use of other CE-marked BVI products used during the surgery, including silicone oils, perfluorocarbon liquids (PFCLs) and gases
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
measure: To evaluate user satisfaction with the device
timeFrame: During surgery (intraoperative)
Other outcomes:
measure: Anatomical success (for subgroups vitrectomy and combined procedure):
timeFrame: From surgery until end of treatment at 90 days
measure: Manifest refraction and BCDVA (sphere and cylinder) (for subgroups cataract, vitrectomy and combined procedure):
timeFrame: At 1 day (Visit 1) and at 90 days (Visit 3)
measure: Corneal oedema grading (by slit lamp examination) (for subgroups cataract and combined procedure)
timeFrame: from enrollment until end of treatment at 90 days
measure: Central macular thickness (for subgroups cataract, vitrectomy and combined procedure: within vitrectomy and combined subgroups, group data by Gauge)
timeFrame: from enrollment until end of treatment at 90 days
measure: Endothelial cell count (ECC)
timeFrame: from enrollment until end of treatment at 90 days
measure: Endothelial cell density: (for subgroup cataract):
timeFrame: from enrollment until end of treatment at 90 days
measure: Description of wound architecture before IOL implantation from intra-op OCT (for subgroups cataract and combined)
timeFrame: from enrollment until end of treatment at 90 days
measure: Description of sclerotomy wound closure Visit 1 and Visit 3 post-op (OCT images, vitrectomy and combined sub-groups by Gauge)
timeFrame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
measure: Fundus examination
timeFrame: from enrollment until end of treatment at 90 days
measure: Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):
timeFrame: During surgery (intraoperative)
measure: Rate of sutureless cataract procedure (cataract and combined subgroups):
timeFrame: During surgery (intraoperative)
measure: Success rate of intended surgical procedures (complete cataract removal, successful retinal re-attachment and macular hole closure by Gauge):
timeFrame: During surgery (intraoperative)
measure: Procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
timeFrame: During surgery (intraoperative)
measure: Fluid volume used for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
timeFrame: During surgery (intraoperative)
measure: List of all other medical devices used during the procedure
timeFrame: During surgery (intraoperative)
measure: Learning curve
timeFrame: During surgery (intraoperative)
Locations:
Study officials:
References: