Age Related CataractsClarinexNCT04369482
Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
A study testing Alcon Clareon and Hoya Vivinex in people with Age Related Cataracts, run by Medical University of Vienna at 1 site in Austria.
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 Clareon, 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 40 to 90 years
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Alcon Clareon and Hoya Vivinex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 1 Feb 2023
- 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 to 90 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna Allgemeines Krankenhaus
Vienna, 1090
About this study
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, 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 Clareon, Hoya Vivinex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon ClareonDevice
Implantation of an intraocular lens Alcon Clareon
Hoya VivinexDevice
Implantation of an intraocular lens Hoya Vivinex
| Study group | Role | What they receive |
|---|---|---|
| Alcon Clareon | Active comparator | Implantation of an intraocular lens Alcon Clareon Receives: Device: Hoya Vivinex |
| Hoya Vivinex | Active comparator | Implantation of an intraocular lens Hoya Vivinex Receives: Device: Alcon Clareon |
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 posted30 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
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 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
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369482
- Sponsor's protocol ID
- Clarinex 1560/2014
- Acronym
- Clarinex
- Status last verified
- May 2022
- First submitted
- 27 Apr 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leydolt C, Schartmuller D, Schwarzenbacher L, Prenner V, Danzinger V, Lisy M, Abela-Formanek C, Menapace R. Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial. J Cataract Refract Surg. 2024 Dec 1;50(12):1242-1246. doi: 10.1097/j.jcrs.0000000000001539.
PubMed 39137100
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
- ClinicalTrials.gov ID
- NCT04369482
- Acronym / sponsor ID
- Clarinex / Clarinex 1560/2014
- Conditions
- Age Related Cataracts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 Apr 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 first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, 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 Clareon | Active comparator | Device: Hoya VivinexImplantation of an intraocular lens Alcon Clareon |
| Hoya Vivinex | Active comparator | Device: Alcon ClareonImplantation of an intraocular lens Hoya Vivinex |
Who may qualify
- Ages
- 40 to 90 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 ClareonImplantation of an intraocular lens Alcon Clareon | Device | Hoya Vivinex |
| Hoya VivinexImplantation of an intraocular lens Hoya Vivinex | Device | Alcon Clareon |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 39137100Leydolt C, Schartmuller D, Schwarzenbacher L, Prenner V, Danzinger V, Lisy M, Abela-Formanek C, Menapace R. Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial. J Cataract Refract Surg. 2024 Dec 1;50(12):1242-1246. doi: 10.1097/j.jcrs.0000000000001539.
- 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.
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?
A study testing Alcon Clareon and Hoya Vivinex in people with Age Related Cataracts, run by Medical University of Vienna at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Austria. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT04369482, 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 17 May 2022.