Clinical trial NCT04632784: Clinical Trial With Artiflex Presbyopic (Artiplus)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Presbyopia
Ametropia
Refractive Errors
Myopia
Hyperopia
Keywords: Artiflex Presbyopic
iris-fixated
phakic intraocular lens
PIOL
Ophtec
Artiplus
Lead sponsor: Ophtec BV
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in monocular and binocular uncorrected near visual acuity (UNVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular corrected near visual acuity (CNVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular distance corrected near visual acuity (DCNVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular uncorrected intermediate visual acuity (UIVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular distance corrected intermediate visual acuity (DCIVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular uncorrected distance visual acuity (UDVA)
timeFrame: 3 years
measure: Improvement in monocular and binocular corrected distance visual acuity (CDVA)
timeFrame: 3 years
measure: Defocus evaluation
timeFrame: 3 years
measure: Predictability of the manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Predictability of the manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Predictability of the manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Stability of manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Stability of manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Stability of manifest refraction spherical equivalent (MRSE)
timeFrame: 3 years
measure: Evaluation of visual disturbances using a validated questionnaire
timeFrame: 3 years
measure: Evaluation of visual disturbances using a validated questionnaire
timeFrame: 3 years
measure: Evaluation of visual disturbances using a validated questionnaire
timeFrame: 3 years
measure: Evaluation of visual disturbances using a validated questionnaire
timeFrame: 3 years
measure: Evaluation of visual disturbances using a validated questionnaire
timeFrame: 3 years
measure: Satisfaction questionnaire
timeFrame: 3 years
measure: Endothelial cell density
timeFrame: 3 years
measure: Endothelial cell density
timeFrame: 3 years
measure: Endothelial cell density
timeFrame: 3 years
measure: Adverse event (AEs) / complication rates
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: GM st. Mary's Eye clinic
city: Seoul
country: Korea, Republic of
facility: SU Yonsei Eye Clinic
city: Seul
country: Korea, Republic of
facility: Nune Eye Hospital Daegu
city: Bilbao
country: Spain
facility: ICQO
state: Biscay
city: Barcelona
country: Spain
facility: IMO
state: Catalonia
city: Madrid
country: Spain
facility: Hospital San Rafael
city: Seville
country: Spain
facility: CIMO
Study officials:
affiliation: Instituto de Microcirugía Ocular, Barcelona, Spain
name: J. Guell, MD
role: PRINCIPAL_INVESTIGATOR
References: