Sign in

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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Eye Clinic Falu Hosptal
Coordinator of this site? Confirm its status
FalunSwedenUnknown status
Opthalmic Clinic University Hospital Linköping
Coordinator of this site? Confirm its status
LinköpingSwedenUnknown status
Ögonläkargruppen Odenplan
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Optalmica Eye Clinic
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Optalmic Clinic Uddevalla Hospital
Coordinator of this site? Confirm its status
UddevallaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.