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Active, not recruitingNCT04632784Updated Oct 15, 2026

Clinical Trial With Artiflex Presbyopic (Artiplus)

An interventional study of Artiflex Presbyopic (Artiplus) implantation in Presbyopia, Ametropia and Refractive Errors, sponsored by Ophtec BV. Active, not recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Ophtec BV · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026First site in South KoreaNo longer in Korea, Republic of+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Presbyopia
  • Ametropia
  • Refractive Errors
  • Myopia
  • Hyperopia

Keywords

  • Artiflex Presbyopic
  • iris-fixated
  • phakic intraocular lens
  • PIOL
  • Ophtec
  • Artiplus
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 49 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Ophtec BV is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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
  • Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study

Exclusion criteria

Exclusion Criteria:

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
  • 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
  • responder
  • Pregnant or nursing
  • Unstable refraction (≥ 0.5D of variability in refraction over the last 12 months)
  • Aged under 18
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (estimated)

Study arms

  • Experimental
    Artiflex Presbyopic (Artiplus)

    49 subjects have received the Artiflex Presbyopic lens (Artiplus) bilaterally and will be followed for 3 years.

    Device: Artiflex Presbyopic (Artiplus) implantation

Interventions

  • DeviceArtiflex Presbyopic (Artiplus) implantation

    Implantation of iris-fixated multifocal Artiflex Presbyopic IOL (Artiplus)

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 years

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 3 years

  12. Stability of manifest refraction spherical equivalent (MRSE)

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 years

  16. Evaluation of visual disturbances using a validated questionnaire

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

    Time frame: 3 years

  17. Evaluation of visual disturbances using a validated questionnaire

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

    Time frame: 3 years

  18. Evaluation of visual disturbances using a validated questionnaire

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

    Time frame: 3 years

  19. Evaluation of visual disturbances using a validated questionnaire

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

    Time frame: 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

    Time frame: 3 years

  21. Endothelial cell density

    Comparison of the preoperative and postoperative endothelial cell density

    Time frame: 3 years

  22. Endothelial cell density

    Endothelial cell loss over time

    Time frame: 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

    Time frame: 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

    Time frame: 3 years

07

Study locations

7 sites
  • GM st. Mary's Eye clinic
    Busan, Busan, South Korea
  • Nune Eye Hospital Daegu
    Seoul, Seoul, South Korea
  • SU Yonsei Eye Clinic
    Seoul, Seoul, South Korea
  • ICQO
    Bilbao, Biscay, Spain
  • IMO
    Barcelona, Catalonia, Spain
  • Hospital San Rafael
    Madrid, Madrid, Spain
  • CIMO
    Seville, Seville, Spain
08

References and documents

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 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Nov 2023, 24 months.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 24 months is above that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2020
First posted
Nov 17, 2020
StartActual
Nov 12, 2021
Primary completionActual
Nov 26, 2023
CompletionEst.
Nov 26, 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites added, 5 sites removed — first site in South Korea; no longer in Korea, Republic of
Show 5 added (3 South Korea, 2 Spain)
  • GM st. Mary's Eye clinic · Busan, South Korea
  • Nune Eye Hospital Daegu · Seoul, South Korea
  • SU Yonsei Eye Clinic · Seoul, South Korea
  • Hospital San Rafael · Madrid, Spain
  • CIMO · Seville, Spain
Show 5 removed
  • GM st. Mary's Eye clinic · Busan, Korea, Republic of
  • SU Yonsei Eye Clinic · Seoul, Korea, Republic of
  • Nune Eye Hospital Daegu · Seul, Korea, Republic of
  • Hospital San Rafael · Madrid, Spain
  • CIMO · Seville, Spain
Oct 15, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 40524363 ↗
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 40524363 ↗
    5 sites added, 5 sites removed — first site in South Korea; no longer in Korea, Republic of
    Show 5 added (3 South Korea, 2 Spain)
    • GM st. Mary's Eye clinic · Busan, South Korea
    • Nune Eye Hospital Daegu · Seoul, South Korea
    • SU Yonsei Eye Clinic · Seoul, South Korea
    • Hospital San Rafael · Madrid, Spain
    • CIMO · Seville, Spain
    Show 5 removed
    • GM st. Mary's Eye clinic · Busan, Korea, Republic of
    • SU Yonsei Eye Clinic · Seoul, Korea, Republic of
    • Nune Eye Hospital Daegu · Seul, Korea, Republic of
    • Hospital San Rafael · Madrid, Spain
    • CIMO · Seville, Spain
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04632784
Lead sponsor
Ophtec BV
Responsible party
Sponsor
First posted
Nov 17, 2020
Start date
Nov 12, 2021
Primary completion
Nov 26, 2023
Completion
Nov 26, 2026 (estimated)
Last update
Oct 15, 2026

Study contacts

J. Guell, MD
principal investigator · Instituto de Microcirugía Ocular, Barcelona, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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