A Clinical Investigation of MINIVISC® PLUS 14 mg/ml Fermented Ophthalmic Viscosurgical Device (OV… (NCT07184437) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Investigation of MINIVISC® PLUS 14 mg/ml Fermented Ophthalmic Viscosurgical Device (OVD-F), Used for Cataract Surgery and Implantation of Intraocular Lenses, Glaucoma Surgery, Anterior Segment Surgery and Corneal Transplantation (CGAC)
Belgium, Sweden134 participantsStarted 2024-02-20
Plain-language summary
A clinical investigation to confirm the clinical safety and performance of OVD-F device MINIVISC® PLUS 1.4 % for cataract surgery and implantation of intraocular lenses, glaucoma surgery, anterior segment surgery and corneal transplantation.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
âś“. Male or Female, \>18 years, in need of ophthalmic surgery for:
âś“. Able and willing to give informed consent for participation in the investigation.
âś“. For the participation in Phase A of the study, patients that need surgery on one or both eyes will be included. For the participation in Phase B of the study, patients that need surgery on one or both eyes will be included but only one eye can be included in the clinical investigation.
Exclusion criteria
âś•. Pregnant or lactating females.
âś•. Any previous hypersensitivity reaction to any constituent of the IMD.
âś•. Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial.
âś•. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject.
✕. Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
âś•. An endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively, based on the average of the three cell counts as taken by the Specular Microscope (only in Phase A).
âś•. Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator, including but not exclusive to diagnosis of wide-angle glaucoma, severe myopia, uveitis, and physical traits such as a small pupil, an extremely shallow anterior chamber, or a compromised endothelial cell function.
What they're measuring
1
Primary efficacy endpoint is the postoperative intraocular pressure (IOP)
âś•. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.