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)

Bohus Biotech AB134 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Cataract

Interventions

OVD-F device Minivisc®PLUS 14 mg/mlDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (6)

UZ Leuven

Leuven, Belgium

Eye Clinic Falu Hosptal

Falun, Dalarna County, Sweden

Ögonläkargruppen Odenplan

Stockholm, Stockholm County, Sweden

Optalmica Eye Clinic

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

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).

Time frame: 7 days

Secondary Outcomes

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

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, at the 2-hour post-surgery follow-up, and at the 7-, 30- and 90-days follow-up visits, as applicable according to the investigational design.

Time frame: +2hours, 7, 30 and 90 days,

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

The central corneal endothelial cell density (cells/mm2), as measured by Specular Microscope images, pre-surgery and at 90 days ± 14 days post-surgery (only Phase A).

Time frame: 90 days

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

Principal investigator evaluation of adverse events during surgery, and at all follow-up visits, as applicable according to the investigational design.

Time frame: 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

Investigator/surgeon evaluation of IMD performance, immediately post-surgery, through ratings of a number of performance related criteria.

Data from ClinicalTrials.gov

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