Age Related CataractsAcryviviNCT04196673
Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses
A study testing Alcon SN60WF and Hoya Vivinex in people with Age Related Cataracts, run by Medical University of Vienna.
Trial summary
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Alcon SN60WF and Hoya Vivinex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 23 Aug 2019
- 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 50 to 100 years
- 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 has planned
- Age 50 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Preceding intraocular surgery or ocular trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
- Laser treatment
- Uncontrolled systemic or ocular disease
- Infectious disease
- Pregnancy/Nursing
About this study
Official title: Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
- Conditions
- Age Related Cataracts
- Being tested
- Alcon SN60WF, Hoya Vivinex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon SN60WFDevice
Implantation of an intraocular lens Alcon SN60WF
Hoya VivinexDevice
Implantation of an intraocular lens Hoya Vivinex
| Study group | Role | What they receive |
|---|---|---|
| Alcon SN60WF | Experimental | Implantation of an intraocular lens Alcon SN60WF Receives: Device: Alcon SN60WF |
| Hoya Vivinex | Experimental | Implantation of an intraocular lens Hoya Vivinex Receives: Device: Hoya Vivinex |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO score
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Measured: 3 years
Secondary outcomes (4)
Visual Acuity
UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
Measured: 3 years
Fibrosis
grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Measured: 3 years
Subjective glistening score
neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
Measured: 3 years
YAG capsulotomy rate
described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Sep 2015
- Primary completion19 Jun 2016
- Study completion23 Aug 2019
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
- 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 randomized 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, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
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
- Investigators
- Rupert Menapace, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196673
- Sponsor's protocol ID
- 1560/2014
- Acronym
- Acryvivi
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 12 Dec 2019
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
- ClinicalTrials.gov ID
- NCT04196673
- Acronym / sponsor ID
- Acryvivi / 1560/2014
- Conditions
- Age Related Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 19 Jun 2016 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 12 Dec 2019 (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 first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- 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 randomized 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, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
| Arm | Type | Receives |
|---|---|---|
| Alcon SN60WF | Experimental | Device: Alcon SN60WFImplantation of an intraocular lens Alcon SN60WF |
| Hoya Vivinex | Experimental | Device: Hoya VivinexImplantation of an intraocular lens Hoya Vivinex |
Who may qualify
- Ages
- 50 to 100 years
- 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 has planned
- Age 50 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (6 listed)
- Preceding intraocular surgery or ocular trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
- Laser treatment
- Uncontrolled systemic or ocular disease
- Infectious disease
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 |
|---|---|---|
| Alcon SN60WFImplantation of an intraocular lens Alcon SN60WF | Device | Alcon SN60WF |
| Hoya VivinexImplantation of an intraocular lens Hoya Vivinex | Device | Hoya Vivinex |
Primary outcome
PCO score
Time frame: 3 years
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
4 secondary outcomes
Visual Acuity
Time frame: 3 years
Fibrosis
Time frame: 3 years
Subjective glistening score
Time frame: 3 years
YAG capsulotomy rate
Time frame: 3 years
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 12 Dec 2019.
- 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.
Rupert Menapace, Prof. Dr. principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing Alcon SN60WF and Hoya Vivinex 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 6 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 12 Dec 2019. 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?
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?
PCO score (time frame: 3 years). 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 12 Dec 2019.