Clinical Trial With Artiflex Presbyopic (Artiplus)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Refractive Errors; Presbyopia; Myopia; Hyperopia; Ametropia
• Intervention / Treatment: Device: Artiflex Presbyopic (Artiplus) implantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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
• Corticosteroid responder
• Pregnant or nursing
• Unstable refraction (≥ 0.5D of variability in refraction over the last 12 months)
• Aged under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Implantation of iris-fixated multifocal Artiflex Presbyopic IOL (Artiplus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	3 years
Predictability of the manifest refraction spherical equivalent (MRSE)	The absolute difference between the actually obtained MRSE and the target MRSE	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	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	3 years
Stability of manifest refraction spherical equivalent (MRSE)	Mean change in MRSE between visits as determined by a paired analysis	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	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	3 years
Evaluation of visual disturbances using a validated questionnaire	Assessing the percentage of subjects who experience different visual disturbances, by means of questionnaire	3 years
Evaluation of visual disturbances using a validated questionnaire	Assessing the occurrence of the different visual disturbances by means of questionnaire	3 years
Evaluation of visual disturbances using a validated questionnaire	Assessing the severity of the different visual disturbances by means of questionnaire	3 years
Evaluation of visual disturbances using a validated questionnaire	Assessing the bothersomeness of the different visual disturbances by means of questionnaire	3 years
Evaluation of visual disturbances using a validated questionnaire	Assessing the time of onset of visual disturbances by means of questionnaire	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	3 years
Endothelial cell density	Comparison of the preoperative and postoperative endothelial cell density	3 years
Endothelial cell density	Endothelial cell loss over time	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	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	3 years

Collaborators and Investigators

• Sponsor: Ophtec BV
• Investigators: Principal Investigator: J. Guell, MD, Instituto de Microcirugía Ocular, Barcelona, Spain

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Actual): November 26, 2023
• Study Completion (Estimated): November 26, 2026

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: iris-fixated; phakic intraocular lens; PIOL; Ophtec; Artiflex Presbyopic; Artiplus
• Additional Relevant MeSH Terms: Eye Diseases; Hyperopia; Presbyopia; Refractive Errors
• Other Study ID Numbers: AP01000816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No