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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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

Other trials in Spain

South Korea3 sites

  • GM st. Mary's Eye clinic

    Busan, Busan

  • Nune Eye Hospital Daegu

    Seoul, Seoul

  • SU Yonsei Eye Clinic

    Seoul, Seoul

Other trials in South Korea

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.

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 groups in NCT04632784
Study groupRoleWhat they receive
Artiflex Presbyopic (Artiplus)Experimental49 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Predictability of the manifest refraction spherical equivalent (MRSE)

    The absolute difference between the actually obtained MRSE and the target MRSE

    Measured: 3 years

  10. 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

  11. 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

  12. Stability of manifest refraction spherical equivalent (MRSE)

    Mean change in MRSE between visits as determined by a paired analysis

    Measured: 3 years

  13. 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

  14. 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

  15. 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

  16. Evaluation of visual disturbances using a validated questionnaire

    Assessing the occurrence of the different visual disturbances by means of questionnaire

    Measured: 3 years

  17. Evaluation of visual disturbances using a validated questionnaire

    Assessing the severity of the different visual disturbances by means of questionnaire

    Measured: 3 years

  18. Evaluation of visual disturbances using a validated questionnaire

    Assessing the bothersomeness of the different visual disturbances by means of questionnaire

    Measured: 3 years

  19. Evaluation of visual disturbances using a validated questionnaire

    Assessing the time of onset of visual disturbances by means of questionnaire

    Measured: 3 years

  20. 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

  21. Endothelial cell density

    Comparison of the preoperative and postoperative endothelial cell density

    Measured: 3 years

  22. Endothelial cell density

    Endothelial cell loss over time

    Measured: 3 years

  23. 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

  24. 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.

  1. First posted17 Nov 2020
  2. Study start12 Nov 2021
  3. Primary completion26 Nov 2023
  4. Study completion26 Nov 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A study testing Artiflex Presbyopic (Artiplus) implantation in people with Presbyopia and Ametropia, run by Ophtec BV at 7 sites in 2 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 30 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, South Korea. 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?

This study is still under way. Results are not available in the source record yet.

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 near visual acuity (UNVA) (time frame: 3 years). The study lists 24 primary outcomes in all. 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 NCT04632784, 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 15 Oct 2026.

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