PresbyopiaNCT04632784
Clinical Trial With Artiflex Presbyopic (Artiplus)
A study testing Artiflex Presbyopic (Artiplus) implantation in people with Presbyopia and Ametropia, run by Ophtec BV at 7 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Ametropia, Refractive Errors
- What is being tested?
- Artiflex Presbyopic (Artiplus) implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Nov 2021to 26 Nov 2026
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presbyopic adult
- Potential for binocular vision
- Subject wishes to be spectacle independent for near and far vision
- Refractive error that can be corrected with correction at PIOL plane from +2.0 to -15.0 D
- Subject requiring a presbyopic correction Patients with reading glasses of minimum +1D.
- Stable refraction (±0.75 D), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history
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- Expected best corrected visual acuity of 0.2 logMAR (0.63 Snellen decimal) or better after lens implantation
- Current contact lens wearer should demonstrate a stable refraction (± 0.5 D), expressed as subjective refraction spherical equivalent, on two consecutive examination dates performed at least 7 days apart. Before the first refraction, the contact lens wearer should not have worn lenses for at least 2 weeks in case of rigid and toric contact lenses, or 3 days for spherical soft contact lenses.
- Any subject, who is expected to have a residual postoperative cylindrical refractive error of below 0.75 D
- Ability to give informed consent
- Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
Who cannot join
- Pre-existing pathology or physiology which may be aggravated by the implant or where the implant may interfere with the possibility of examining or treating disease:
- Preoperative ocular or systemic condition or medication use that would be expected to present undue risk to the subject, that can predispose for future complications or confound the outcome(s) of the study. E.g. the systemic use of alpha-1a adrenergic receptor antagonists was suggested to increase the occurrence of intraoperative floppy iris syndrome, alter iris morphology - or more specifically reduce iris thickness at the site of potential IOL enclavation - and increase postoperative endothelial cell loss.
- Previous ocular surgery which might affect the outcome of the study
- Concurrent participation or participation during the last 30 days in another drug or device investigation
- Secondary surgical procedure planned during the first 6 months of the study (e.g. laser treatment to correct astigmatism)
- Amblyopia
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- Preoperative anterior chamber depth measurement of below 3.0 mm for subjects < 40 years old and 2.8 mm for subjects > 40 years old. Anterior chamber depth is being measured from corneal endothelium to the anterior pole of the crystalline lens. This will result in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging.
- White-to-white smaller than 10.5 mm
- Subjects not meeting the age specific minimum preoperative endothelial cell density as defined below:
- 31 to 35 years of age 2400 cells/mm2; 36 to 45 years of age 2200 cells/mm2; > 45 years of age 2000 cells/mm2
- Corneas with high rates of polymegethism (a coefficient of variation over 0.40) and pleomorphism (the presence of less than 50% hexagonal cells).
- Abnormal iris (e.g. convex, bulging or volcano shaped iris)
- Crystalline lens rise of 600 µm or more
- Abnormal cornea (keratoconus, opaque cornea, corneal scars, post corneal transplant, corneal dystrophy, or other)
- Ocular surface conditions which might influence the quality of vision and affect the outcome of the study
- Abnormal pupil (e.g. nonreactive, fixed)
- Ectopic pupil
- Pupil in photopic light conditions smaller than 2.6 mm
- Pupil in scotopic light conditions greater than 7.0 mm
- High preoperative intraocular pressure (>21 mm Hg)
- Cataract of any grade
- Glaucoma or family history of glaucoma (dependent on the evaluation of physician)
- Diabetes or diabetic retinopathy
- Acute or chronic inflammation
- Chronic or recurrent uveitis or family history of the same condition
- Retinal detachments or family history of retinal detachments
- Corticosteroid responder
- Pregnant or nursing
- Unstable refraction (≥ 0.5D of variability in refraction over the last 12 months)
- Aged under 18
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain4 sites
IMO
Barcelona, Catalonia
ICQO
Bilbao, Biscay
Hospital San Rafael
Madrid, Madrid
CIMO
Seville, Seville
South Korea3 sites
GM st. Mary's Eye clinic
Busan, Busan
Nune Eye Hospital Daegu
Seoul, Seoul
SU Yonsei Eye Clinic
Seoul, Seoul
About this study
Official title: Prospective Multicentre Clinical Trial With the Artiflex Presbyopic (Artiplus), an Iris-fixated Multifocal Intraocular Lens for the Correction of Presbyopia in Phakic Eyes
The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.
Read the detailed description
The study is a prospective, open-label, single-arm, and multicentre clinical investigation with three years of follow-up. Artiflex Presbyopic (Artiplus) is a phakic intraocular lens to be implanted in the anterior chamber, intended for adult subjects and indicated for the optical correction of presbyopia and spherical error requiring a correction.
- Conditions
- Presbyopia, Ametropia, Refractive Errors, Myopia, Hyperopia
- Being tested
- Artiflex Presbyopic (Artiplus) implantation
- Keywords
- Artiflex Presbyopic, iris-fixated, phakic intraocular lens, PIOL, Ophtec, Artiplus
- Medical subject headings
- Presbyopia, Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artiflex Presbyopic (Artiplus) implantationDevice
Implantation of iris-fixated multifocal Artiflex Presbyopic IOL (Artiplus)
| Study group | Role | What they receive |
|---|---|---|
| Artiflex Presbyopic (Artiplus) | Experimental | 49 subjects have received the Artiflex Presbyopic lens (Artiplus) bilaterally and will be followed for 3 years. Receives: Device: Artiflex Presbyopic (Artiplus) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in monocular and binocular uncorrected near visual acuity (UNVA)
- Percentage of eyes that achieve UNVA of 0.3 logMAR or better
- Percentage of eyes that achieve UNVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular corrected near visual acuity (CNVA)
- Percentage of eyes that achieve CNVA of 0.3 logMAR or better
- Percentage of eyes that achieve CNVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular distance corrected near visual acuity (DCNVA)
- Percentage of eyes that achieve DCNVA of 0.3 logMAR or better
- Percentage of eyes that achieve DCNVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular uncorrected intermediate visual acuity (UIVA)
- Percentage of eyes that achieve UIVA of 0.3 logMAR or better
- Percentage of eyes that achieve UIVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular distance corrected intermediate visual acuity (DCIVA)
- Percentage of eyes that achieve DCIVA of 0.3 logMAR or better
- Percentage of eyes that achieve DCIVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular uncorrected distance visual acuity (UDVA)
Percentage of eyes that achieve UDVA of 0.3 logMAR or better Percentage of eyes that achieve UDVA of 0.0 logMAR or better
Measured: 3 years
Improvement in monocular and binocular corrected distance visual acuity (CDVA)
- Percentage of eyes that achieve CDVA of 0.3 logMAR or better
- Percentage of eyes that achieve CDVA of 0.0 logMAR or better
Measured: 3 years
Defocus evaluation
Binocular defocus evaluation will be obtained by using the best-corrected distance refraction and then defocusing the image in 0.5 D increments from +1.5 to -5.0 D
Measured: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The absolute difference between the actually obtained MRSE and the target MRSE
Measured: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a MRSE of less than or equal to 0.5 D difference between the actual and target MRSE
Measured: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a MRSE of less than or equal to 1.0 D difference between the actual and target MRSE
Measured: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
Mean change in MRSE between visits as determined by a paired analysis
Measured: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a change in MRSE of less than or equal to 0.5 D between two consecutive refraction measurements
Measured: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a change in MRSE of less than or equal to 1.0 D between two consecutive refraction measurements
Measured: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the percentage of subjects who experience different visual disturbances, by means of questionnaire
Measured: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the occurrence of the different visual disturbances by means of questionnaire
Measured: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the severity of the different visual disturbances by means of questionnaire
Measured: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the bothersomeness of the different visual disturbances by means of questionnaire
Measured: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the time of onset of visual disturbances by means of questionnaire
Measured: 3 years
Satisfaction questionnaire
- Percentage of subjects that is satisfied with the overall procedure
- Percentage of subjects that is satisfied with uncorrected near vision
- Percentage of subjects that is satisfied with uncorrected intermediate vision
- Percentage of subjects that is satisfied with uncorrected distance vision
Measured: 3 years
Endothelial cell density
Comparison of the preoperative and postoperative endothelial cell density
Measured: 3 years
Endothelial cell density
Endothelial cell loss over time
Measured: 3 years
Endothelial cell density
Additionally, a comparison between the scientific literature reported naturally occurring endothelial cell loss over time (approx. 0.6% per year; Bourne et al., 1997) and the study observed cell loss will be performed
Measured: 3 years
Adverse event (AEs) / complication rates
- Cumulative numbers of adverse events, e.g. cystoid macular edema (CME), hypopyon, endophthalmitis, lens dislocation, pupillary block, retinal detachment, necessary secondary surgical interventions
- Cumulative numbers of adverse events persistently present, e.g. corneal stroma edema, cystoid macular edema, iritis, raised intraocular pressure (IOP) requiring treatment, lens deposits
- The occurrence of adverse events will be compared to and should not exceed the reference safety and performance endpoint (SPE) rates as defined by ISO 11979-7:2018, Annex E, table E.1
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 posted17 Nov 2020
- Study start12 Nov 2021
- Primary completion26 Nov 2023
- Study completion26 Nov 2026 (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 PresbyopiaStudies 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophtec BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Guell, MD, Principal investigator, Instituto de Microcirugía Ocular, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632784
- Sponsor's protocol ID
- AP01000816
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wanten JC, Cezon J, Nuijts RMMA, Duran de la Colina JA, Royo M, Choe CM, Choi JH, Park CS, Koh IH, Rodriguez DC, Bauer NJC, Guell JL. Six-month performance and safety of an iris-fixated multifocal intraocular lens for presbyopia correction in phakic eyes. J Cataract Refract Surg. 2025 Nov 1;51(11):963-971. doi: 10.1097/j.jcrs.0000000000001722.
PubMed 40524363