NCT07184437Completed
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)
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 134 (actual)
- First submitted
- 6 Aug 2024
- Start date
- 20 Feb 2024
- Primary completion date
- 19 Jun 2025
- Lead sponsor
- Bohus Biotech AB
- Diseases
- Glaucoma
- NCT number
- NCT07184437
What you commit to
- Study type: Interventional
- Participants enrolled: 134
- From 20 Feb 2024 to the primary completion date, 19 Jun 2025
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous hypersensitivity reaction to any constituent of the IMD.
- Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial.
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject.
Other illness
- Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
- 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.
Lab values
- 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).
Other
- Pregnant or lactating females.
- Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.
Who the study is looking for
- Male or Female, \>18 years, in need of ophthalmic surgery for:
- Cataract
- Glaucoma surgery
- Anterior segment trauma or diseases
- Damaged or diseased cornea
- Able and willing to give informed consent for participation in the investigation.
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Eye Clinic Falu Hosptal Coordinator of this site? Confirm its status | Falun | Sweden | Unknown status |
| Opthalmic Clinic University Hospital Linköping Coordinator of this site? Confirm its status | Linköping | Sweden | Unknown status |
| Ögonläkargruppen Odenplan Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Optalmica Eye Clinic Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Optalmic Clinic Uddevalla Hospital Coordinator of this site? Confirm its status | Uddevalla | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.