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)

NCT07184437 | Completed

• 1 other identifier: CIV-23-10-044394
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 6

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 segment surgery and corneal transplantation.

Conditions

Cataract

Keywords

Cataract surgery; Implantation of intraocular lenses; Glaucoma surgery; Anterior segment surgery; Corneal transplantation

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint is the postoperative intraocular pressure (IOP)

  The primary endpoint is the postoperative intraocular pressure (IOP). A patient is defined as a failure if the IOP ≥ 30 mmHg within 7 days post-surgery (Data from Phase A and Phase B pooled, IMD only).

  7 days

Secondary Outcomes (4)

• Secondary endpoint is the Postoperative inflammation, as measured by slit-lamp bio-microscopy, and graded using a standard grading system, such as The Standardization of Uveitis Nomenclature (SUN) Working group

  +2hours, 7, 30 and 90 days,

• Secondary endpoint is the central corneal endothelial cell density (cells/mm2), as measured by Specular Microscope images.

  90 days

• Secondary endpoint Principal investigator evaluation of adverse events during surgery, and at all follow-up visits.

  Assessed during the whole study, in Phase A up to 90 (+/-14d) days, and in Phase B up to 30 (+/- 7d) days.

• Secondary endpoint is Investigator/surgeon evaluation of IMD performance through ratings of a number of performance related criteria

  Assessed by surgeon after surgery +2h

Study Arms (2)

Phase A

ACTIVE COMPARATOR

In Phase A, eligible subjects will undergo surgery on one or both eyes. In case of both eye surgery, subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml) in one eye and the control OVD (Healon GV® PRO 18 mg/ml OVD) in the other eye. OVDs will be randomly assigned by investigator to each eye to reach an as even as possible distribution of the IMD and comparator. In case of one eye surgery, MINIVISC® PLUS 14 mg/ml OR Healon GV® PRO 18 mg/ml will be randomly assigned to the eye. Healon GV® PRO 18 mg/ml OVD is a legally marketed alternative with similar indications for use and similar properties as the MINIVISC®PLUS 14 mg/ml OVD.

Device: OVD-F device Minivisc®PLUS 14 mg/ml

Phase B

OTHER

In the Phase B, eligible subjects will undergo surgery on one eye. The subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml OVD).

Device: OVD-F device Minivisc®PLUS 14 mg/ml

Interventions

OVD-F device Minivisc®PLUS 14 mg/ml DEVICE

MINIVISC® PLUS 14 mg/ml is intended to protect, lubricate and support delicate ophthalmic cells or tissues, to assist in maintaining intraocular space and to enhance visualization during surgery.

Phase A; Phase B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bohus Biotech AB: lead
• Key2Compliance: collaborator

Study Sites (6)

UZ Leuven

Leuven, 3000, Belgium

Location

Eye Clinic Falu Hosptal

Falun, Dalarna County, 791 82, Sweden

Location

Ögonläkargruppen Odenplan

Stockholm, Stockholm County, 113 22, Sweden

Location

Optalmica Eye Clinic

Stockholm, Stockholm County, 183 34, Sweden

Location

Optalmic Clinic Uddevalla Hospital

Uddevalla, Västra Götaland County, 451 53, Sweden

Location

Opthalmic Clinic University Hospital Linköping

Linköping, Östergötland County, 581 85, Sweden

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Björn Johansson, MD

  Opthalmic Clinic University Hospital Linköping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Phase A, eligible subjects will undergo surgery on one or both eyes. In case of both eye surgery, subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml) in one eye and the control OVD (Healon GV® PRO 18 mg/ml OVD) in the other eye. In case of one eye surgery, MINIVISC® PLUS 14 mg/ml OR Healon GV® PRO 18 mg/ml will be randomly assigned to the eye. In Phase B, eligible subjects will undergo surgery on one eye. The subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml OVD).

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2025
• Study Start: February 20, 2024
• Primary Completion: June 19, 2025
• Study Completion: July 29, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5); BE (1)