Status:
COMPLETED
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)
Lead Sponsor:
Bohus Biotech AB
Collaborating Sponsors:
Key2Compliance
Conditions:
Cataract
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 seg...
Detailed Description
The investigation will include two phases, Phase A and Phase B. The duration of the patient follow-up in Phase A is 90 days, in Phase B - 7 days, alternatively 30 days, depending on intraocular pressu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant or lactating females.
- 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.
- Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
- 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).
- 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.
- Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2025
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT07184437
Start Date
February 20 2024
End Date
July 29 2025
Last Update
September 19 2025
Active Locations (6)
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1
UZ Leuven
Leuven, Belgium, 3000
2
Eye Clinic Falu Hosptal
Falun, Dalarna County, Sweden, 791 82
3
Ögonläkargruppen Odenplan
Stockholm, Stockholm County, Sweden, 113 22
4
Optalmica Eye Clinic
Stockholm, Stockholm County, Sweden, 183 34