Age Related CataractsNCT04230629
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
A study testing Vivinex XY1 and Vivinex XY1A in people with Age Related Cataracts, run by Medical University of Vienna.
Trial summary
On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Vivinex XY1 and Vivinex XY1A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 30 Jun 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- Age 40 and older
- Astigmatism of at least 0.75Diopters in one eye
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Diabetes mellitus
- Pseudoexfoliation syndrome
- Systemical anticoagulation
- Antiphlogistic therapy
- Antiglaucomatosa
- Uncontrolled systemic or ocular disease
Show all 10Show fewer
- Preceding ocular surgery or trauma
- Intraoperative complications
- Pregnancy/Nursing
- Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Trial locations and contacts
No sites are listed yet.
About this study
On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.
A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.
- Conditions
- Age Related Cataracts
- Being tested
- Vivinex XY1, Vivinex XY1A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivinex XY1Device
Implantation of an intraocular lens Hoya Vivinex XY1
Vivinex XY1ADevice
Implantation of an intraocular lens Hoya Vivinex XY1A
| Study group | Role | What they receive |
|---|---|---|
| Vivinex XY1 | Active comparator | Implantation of an intraocular lens Hoya Vivinex XY1 Receives: Device: Vivinex XY1 |
| Vivinex XY1A | Active comparator | Implantation of an intraocular lens Hoya Vivinex XY1A Receives: Device: Vivinex XY1A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of FBGC (foreign body giant cells) (slitlamp examination)
The number of foreign body giant cells on the IOLs will be assessed.
Measured: 5 months
Secondary outcomes (4)
Incidence of Monocytes (slitlamp examination)
The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2
Measured: 5 months
PCO Score (slitlamp examination)
Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Measured: 5 months
Grade of Anterior Fibrosis (slitlamp examination)
Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Measured: 5 months
Anterior chamber reaction (slitlamp examination)
Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Mar 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230629
- Sponsor's protocol ID
- 2060/2019
- Status last verified
- Mar 2021
- First submitted
- 10 Jan 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
- ClinicalTrials.gov ID
- NCT04230629
- Acronym / sponsor ID
- 2060/2019
- Conditions
- Age Related Cataracts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Jan 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.
On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.
A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.
| Arm | Type | Receives |
|---|---|---|
| Vivinex XY1 | Active comparator | Device: Vivinex XY1Implantation of an intraocular lens Hoya Vivinex XY1 |
| Vivinex XY1A | Active comparator | Device: Vivinex XY1AImplantation of an intraocular lens Hoya Vivinex XY1A |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- Age 40 and older
- Astigmatism of at least 0.75Diopters in one eye
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (10 listed)
- Diabetes mellitus
- Pseudoexfoliation syndrome
- Systemical anticoagulation
- Antiphlogistic therapy
- Antiglaucomatosa
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 |
|---|---|---|
| Vivinex XY1Implantation of an intraocular lens Hoya Vivinex XY1 | Device | Vivinex XY1 |
| Vivinex XY1AImplantation of an intraocular lens Hoya Vivinex XY1A | Device | Vivinex XY1A |
Primary outcome
Number of FBGC (foreign body giant cells) (slitlamp examination)
Time frame: 5 months
The number of foreign body giant cells on the IOLs will be assessed.
4 secondary outcomes
Incidence of Monocytes (slitlamp examination)
Time frame: 5 months
PCO Score (slitlamp examination)
Time frame: 5 months
Grade of Anterior Fibrosis (slitlamp examination)
Time frame: 5 months
Anterior chamber reaction (slitlamp examination)
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Age Related Cataracts
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
Vision Impairment and Blindness, Glaucoma
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
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.
Questions about this trial
What is this clinical trial studying?
A study testing Vivinex XY1 and Vivinex XY1A in people with Age Related Cataracts, run by Medical University of Vienna.
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 10 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rupert Menapace (0140400 ext. 66300, rupert.menapace@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of FBGC (foreign body giant cells) (slitlamp examination) (time frame: 5 months). 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 9 Mar 2021.