Cataract SenileVISPERNCT04252716
VISPER: Randomised Comparison of Two OVDs in Cataract Surgery
An observational study of Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- OVD
- Type of treatment
- Medical device
- How many people
- 273 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2020to 8 Feb 2022
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of cataract surgery
Who may be able to join
- Patients of any gender, 50 years of age or older at the time of study enrolment
- undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only
- Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent
- Planned implantation of the IOL in the capsular bag
Who cannot join
- Patients not able to / willing to give informed consent
- Patients not able to comprehend and comply with study requirements
- Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
- Patients not able to attend follow-up appointments for any reason
- Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
- Patients with reduced corneal endothelium (e.g. Fuch's dystrophy)
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- Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function
- Patients being treated with tocainide for cardiac arrhythmia
- Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels
- Mono-ophthalmic patients
- Patients who have previously undergone cataract surgery in the contralateral eye
- Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain
- VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason
- Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log)
- Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery
- Patients who may require the use of hyaluronidase as part of the study cataract procedure
- Patients who may be regarded as being vulnerable (e.g. prisoners, residents of care or mental health institutions, trauma, war or disaster victims, dependent on the investigator etc.)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013
- Conditions
- Cataract Senile
- Being tested
- OVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVDDevice
Intraocular administration
| Study group | Role | What they receive |
|---|---|---|
| VISTHESIA 1.5 | Ophtalmologic surgery supported by Visthesia OVD Receives: Device: OVD | |
| ProVisc | Ophtalmologic surgery supported by Provisc OVD Receives: Device: OVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg
Measured: 6-hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start24 Sep 2020
- Primary completion24 Nov 2021
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252716
- Sponsor's protocol ID
- Visth 1.5 BER-401-19
- Acronym
- VISPER
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
- ClinicalTrials.gov ID
- NCT04252716
- Acronym / sponsor ID
- VISPER / Visth 1.5 BER-401-19
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 5 Feb 2020 (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.
To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTHESIA 1.5 | – | Device: OVDOphtalmologic surgery supported by Visthesia OVD |
| ProVisc | – | Device: OVDOphtalmologic surgery supported by Provisc OVD |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of cataract surgery
Key inclusion criteria (4 listed)
- Patients of any gender, 50 years of age or older at the time of study enrolment
- undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only
- Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent
- Planned implantation of the IOL in the capsular bag
Key exclusion criteria (17 listed)
- Patients not able to / willing to give informed consent
- Patients not able to comprehend and comply with study requirements
- Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
- Patients not able to attend follow-up appointments for any reason
- Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
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 |
|---|---|---|
| OVDIntraocular administration | Device | ProVisc, VISTHESIA 1.5 |
Primary outcome
IOP
Time frame: 6-hours post-operatively
Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg
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 15 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Germany.
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 4 inclusion and 17 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
IOP (time frame: 6-hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.