CataractMinivisc01NCT07184437
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)
A study testing OVD-F device Minivisc®PLUS 14 mg/ml in people with Cataract, run by Bohus Biotech AB at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- OVD-F device Minivisc®PLUS 14 mg/ml
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Feb 2024to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden5 sites
Eye Clinic Falu Hosptal
Falun, Dalarna County, 791 82
Opthalmic Clinic University Hospital Linköping
Linköping, Östergötland County, 581 85
Ögonläkargruppen Odenplan
Stockholm, Stockholm County, 113 22
Optalmica Eye Clinic
Stockholm, Stockholm County, 183 34
Optalmic Clinic Uddevalla Hospital
Uddevalla, Västra Götaland County, 451 53
About this study
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.
Read the 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 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).
- Conditions
- Cataract
- Being tested
- OVD-F device Minivisc®PLUS 14 mg/ml
- Keywords
- Cataract surgery, Implantation of intraocular lenses, Glaucoma surgery, Anterior segment surgery, Corneal transplantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: OVD-F device Minivisc®PLUS 14 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: +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).
Measured: 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.
Measured: 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.
Measured: Assessed by surgeon after surgery +2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Feb 2024
- Primary completion19 Jun 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model 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. 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).
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bohus Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Responsible party
- Sponsor
- Investigators
- Björn Johansson, MD, Principal investigator, Opthalmic Clinic University Hospital Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184437
- Sponsor's protocol ID
- CIV-23-10-044394
- Acronym
- Minivisc01
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogt C, Xeroudaki M, Fridberg A, Johansson B. Safety and performance of a new cohesive ophthalmic viscosurgical device: multicenter, partially comparative randomized study. J Cataract Refract Surg. 2026 Sep 2. doi: 10.1097/j.jcrs.0000000000002048. Online ahead of print.
PubMed 42684806
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07184437
- Acronym / sponsor ID
- Minivisc01 / CIV-23-10-044394
- Conditions
- Cataract
- Keywords
- Cataract surgery, Implantation of intraocular lenses, Glaucoma surgery, Anterior segment surgery, Corneal transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Bohus Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model 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. 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).
| Arm | Type | Receives |
|---|---|---|
| Phase A | Active comparator | Device: OVD-F device Minivisc®PLUS 14 mg/mlIn 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. |
| Phase B | Other | Device: OVD-F device Minivisc®PLUS 14 mg/mlIn the Phase B, eligible subjects will undergo surgery on one eye. The subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml OVD). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female, >18 years, in need of ophthalmic surgery for:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVD-F device Minivisc®PLUS 14 mg/mlMINIVISC® 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. | Device | Phase A, Phase B |
Primary outcome
Primary efficacy endpoint is the postoperative intraocular pressure (IOP)
Time frame: 7 days
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).
4 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
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.
Time frame: 90 days
Secondary endpoint Principal investigator evaluation of adverse events during surgery, and at all follow-up visits.
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
Time frame: Assessed by surgeon after surgery +2h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42684806Vogt C, Xeroudaki M, Fridberg A, Johansson B. Safety and performance of a new cohesive ophthalmic viscosurgical device: multicenter, partially comparative randomized study. J Cataract Refract Surg. 2026 Sep 2. doi: 10.1097/j.jcrs.0000000000002048. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Johansson, MD principal investigator
Opthalmic Clinic University Hospital Linköping
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OVD-F device Minivisc®PLUS 14 mg/ml in people with Cataract, run by Bohus Biotech AB at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint is the postoperative intraocular pressure (IOP) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.