CataractNCT02409771
Clinical Trial With PRECIZON Presbyopic
A study testing PRECIZON Presbyopic in people with Cataract and Presbyopia, run by Ophtec BV at 6 sites in 5 countries.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- PRECIZON Presbyopic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jun 2015to 17 Jan 2017
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presbyopic
- Cataract patient or Clear Lens Extraction (CLE) candidate
- Patients wishes to be spectacle independent for near and far vision
- Patient lifestyle and outlook fit with multifocal IOL implantation
- Qualifies for bilateral implantation
- Patient must have a calculated IOL power within the available diopter range
Show all 11Show fewer
- Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation.
- No secondary surgical procedure planned during the course of the study
- Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
- Patients must provide written informed consent
- The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be <1.0 D.
Who cannot join
- Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
- Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
- Endothelial cell count <1500 cells/mm2
- Amblyopia
- Congenital eye abnormalities
- Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient
- Concurrent participation or participation during the last 30 days in any other clinical trial
- Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Spain2 sites
Oftalvist CIO Jerez
Jerez de la Frontera, 11408
Hospital Universitari Mútua Terrassa
Terrassa, 08221
Netherlands1 site
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, 6229 HX
About this study
Official title: Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens
The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.
Read the detailed description
Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.
- Conditions
- Cataract, Presbyopia
- Being tested
- PRECIZON Presbyopic
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECIZON PresbyopicDevice
Also called PRECIZON Presbyopic Multifocal intraocular lens (MIOL)
Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Bilateral implantation with PRECIZON Presbyopic intraocular lens Receives: Device: PRECIZON Presbyopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in monocular and binocular uncorrected and corrected near visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity
Measured: 3 months follow-up postoperative
Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity
Measured: 3 months post-op
Improvement in monocular and binocular uncorrected and corrected distance visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity
Measured: 3 months post-op
Secondary outcomes (8)
Photopic contrast sensitivity as measured by a contrast sensitivity chart
Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.
Measured: 3 months postoperative
Mesopic contrast sensitivity as measured by a contrast sensitivity chart
Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.
Measured: 3 months post-op
Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis
Percentage of eyes that achieve a change of less than or equal to 1.00 D of MRSE between two refractions performed 3 months apart
Measured: 3 months post-op
Spectacle dependency
Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision
Measured: 3 months post-op
Defocus curve
Binocular defocus evaluation will be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 D increments to -0.5 D.
Measured: 3 months post-op
Rates of adverse events and complications
Measured: 3 months post-op
Patient satisfaction as measured by a patient satisfaction questionnaire
Measured: 3 months post-op
Quality of vision as measured by the Quality of Vision (QoV) questionnaire
Percentage of patients with a QoV score >10 and >30 at 3 months postoperative
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophtec BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike P. Holzer, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409771
- Sponsor's protocol ID
- AP01000538
- Status last verified
- Apr 2017
- First submitted
- 12 Mar 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT02409771
- Acronym / sponsor ID
- AP01000538
- Conditions
- Cataract, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ophtec BVIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 7 Apr 2015 (estimated)
- 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.
The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.
Detailed description
Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: PRECIZON PresbyopicBilateral implantation with PRECIZON Presbyopic intraocular lens |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presbyopic
- Cataract patient or Clear Lens Extraction (CLE) candidate
- Patients wishes to be spectacle independent for near and far vision
- Patient lifestyle and outlook fit with multifocal IOL implantation
- Qualifies for bilateral implantation
Key exclusion criteria (8 listed)
- Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
- Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
- Endothelial cell count <1500 cells/mm2
- Amblyopia
- Congenital eye abnormalities
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 |
|---|---|---|
| PRECIZON PresbyopicAlso: PRECIZON Presbyopic Multifocal intraocular lens (MIOL)Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction. | Device | Intervention arm |
Primary outcome
Improvement in monocular and binocular uncorrected and corrected near visual acuity
Time frame: 3 months follow-up postoperative
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity
Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity
Time frame: 3 months post-op
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity
Improvement in monocular and binocular uncorrected and corrected distance visual acuity
Time frame: 3 months post-op
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity
8 secondary outcomes
Photopic contrast sensitivity as measured by a contrast sensitivity chart
Time frame: 3 months postoperative
Mesopic contrast sensitivity as measured by a contrast sensitivity chart
Time frame: 3 months post-op
Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis
Time frame: 3 months post-op
Spectacle dependency
Time frame: 3 months post-op
Defocus curve
Time frame: 3 months post-op
Rates of adverse events and complications
Time frame: 3 months post-op
Patient satisfaction as measured by a patient satisfaction questionnaire
Time frame: 3 months post-op
Quality of vision as measured by the Quality of Vision (QoV) questionnaire
Time frame: 3 months post-op
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 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mike P. Holzer, Prof. Dr. principal investigator
Heidelberg University
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECIZON Presbyopic in people with Cataract and Presbyopia, run by Ophtec BV at 6 sites in 5 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 11 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 4 Apr 2017. 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 Spain, Belgium, Germany, Netherlands, Turkey (Türkiye). 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?
Improvement in monocular and binocular uncorrected and corrected near visual acuity (time frame: 3 months follow-up postoperative). The study lists 3 primary outcomes in all. 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 4 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.