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) (Minivisc01)

Bohus Biotech

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184437

CIV-23-10-044394

Details and patient eligibility

About

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.

Full 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 pressure, during which the safety and performance of the IMD will be assessed. AEs will be followed up until resolution or the follow-up assessment, whichever comes first, or according to the judgement of the PI or authorized designee.

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.

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

Enrollment: 134 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female, >18 years, in need of ophthalmic surgery for:

   • Cataract
   • Glaucoma surgery
   • Anterior segment trauma or diseases
   • Damaged or diseased cornea

2. Able and willing to give informed consent for participation in the investigation.

3. 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

1. Pregnant or lactating females.
2. Any previous hypersensitivity reaction to any constituent of the IMD.
3. Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial.
4. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject.
5. Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
6. 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).
7. 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.
8. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Phase A

Active Comparator group

Description:

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.

Treatment:

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

Phase B

Other group

Description:

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

Treatment:

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