The main objective of this study is to evaluate the safety and effectiveness of the Artiflex Presbyopic IOL. It will be studied whether the IOL can provide satisfactory near, intermediate, and distance vision in subjects who desire spectacle…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
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
•
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
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
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
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
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.
Predictability of the manifest refraction spherical equivalent (MRSE)
• The absolute difference between the actually obtained MRSE and the target 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
• The percentage of eyes that achieves a MRSE of less than or equal to 1.0 D
difference between the actual and target MRSE
Stability of manifest refraction spherical equivalent (MRSE)
• Mean change in MRSE between visits as determined by a paired analysis
• The percentage of eyes that achieves a change in MRSE of less than or equal
to 0.5 D between two consecutive refraction measurements
• The percentage of eyes that achieves a change in MRSE of less than or equal
to 1.0 D between two consecutive refraction measurements
Spectacle dependency
• Percentage of subjects that uses glasses for near vision and the frequency of
use
• Percentage of subjects that uses glasses for intermediate vision and the
frequency of use
• Percentage of subjects that uses glasses for distance vision and the
frequency of use
• Percentage of subjects that achieve complete spectacle independence
Contrast sensitivity
• Postoperative binocular photopic contrast sensitivity scores for spatial
frequencies of 3, 6, 12 and 18 cycles per degree (cpd)
• Postoperative binocular mesopic contrast sensitivity scores for spatial
frequencies of 3, 6, 12 and 18 cpd
• Postoperative binocular photopic contrast sensitivity scores in the presence
of glare for spatial frequencies of 3, 6, 12 and 18 cpd
• Postoperative binocular mesopic contrast sensitivity scores in the presence
of glare for spatial frequencies of 3, 6, 12 and 18 cpd
• Comparison of the preoperative and postoperative photopic and mesopic
contrast sensitivity scores with and without the presence of glare
Quality of Vision
• Percentage of subjects that experiences different visual disturbances is
evaluated by a validated questionnaire
• The occurrence of the different visual disturbances
• The severity of the different visual disturbances
• The bothersomeness of the different visual disturbances
• The time of onset of visual disturbances
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
Endothelial cell density
• Comparison of the preoperative and postoperative endothelial cell density
• Endothelial cell loss over time
• Additionally, a comparison between the in the scientific literature reported
naturally occurring endothelial cell loss over time (approx. 0.6% per
year; Bourne et al., 1997) and the in the study observed cell loss will
be performed (EN-ISO 11979-10, section 10.2.1, page 3).
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 (see CIP: Annex E, table E.1).
Secondary outcome
The following objectives are considered secondary:
- To evaluate contrast sensitivity
- To evaluate the defocus
- To evaluate rates of adverse events/complications
- To evaluate patient satisfaction and quality of vision
Background summary
Presbyopia is a very common, age-related impairment of near vision, with an
average onset at approximately 45 years of age. Whereas in Europe and
North-America about 83 percent of the population at the age of 45 years old and
older are affected, the prevalence in Asia and South-America is considerably
lower with respectively 44 and 60 percent. Presbyopia is an impairment of near
vision. Indeed, to be able to see at different distances (near, intermediate,
and far) the eye has the ability to accommodate. During aging, the range of
distances where the eye can focus properly reduces, which ultimately results in
the loss of accommodation capability or presbyopia. Presbyopia may be - and is
often - combined with other visual impairments such as myopia, hyperopia, and
astigmatism. Historically, the treatment of presbyopia has primarily involved
spectacles and contact lenses. However, since spectacles reduce the visual
field and lenses are not tolerated by many subjects, alternative treatment
methods - i.e. refractive laser surgery- are developed for the correction of
refractive errors. Although laser refractive surgery can be a very effective
procedure, it does not always lead to spectacle-independence. Furthermore, the
rather invasive treatment has a limited power range when compared to
intraocular lenses, and also carries several potential side effects and
complications including, corneal scarring, dry eyes, and dysphotopsia. The
newly by Ophtec developed phakic multifocal intraocular lens - the Artiflex
Presbyopic - is based on two lenses currently manufactured by Ophtec, the
Artiflex Myopia, a flexible phakic IOL intended for the correction of myopia,
and the Precizon Presbyopic NVA IOL, which is indicated for the optical
correction of aphakia and presbyopia in adult subjects and is intended for
implantation in the capsular bag. The optical properties of the Artiflex
Presbyopic are based on the multifocal Precizon Presbyopic NVA IOL. Presbyopic
NVA IOL is known to provide satisfactory vision at al distances with a evel of
minimum dysphotopsias like haloes and glare. Expectedly, Implantation of
Artiflex Presbyopic is supposed to result in an improved near, intermediate and
far visual acuity, and thereby in a complete spectacle independency.
Study objective
The main objective of this study is to evaluate the safety and effectiveness of
the Artiflex Presbyopic IOL. It will be studied whether the IOL can provide
satisfactory near, intermediate, and distance vision in subjects who desire
spectacle independency. Study outcomes will be used to obtain CE marking for
the lens and for registration and marketing purposes.
Study design
The study is a prospective, open-label, single-arm, multicentre clinical
investigation with the Artiflex Presbyopic IOL, intended to evaluate the
performance - safety and efficacy - of the lens in adult phakic subjects with
presbyopia. About 125 subjects will receive the Artiflex Presbyopic lens
bilaterally and will be followed for a period of 3 years.
Intervention
Subjects receive the Artiflex Presbyopic multifocal IOL in both eyes. Surgical
procedure and medication regime are standard for intraocular lens implantation.
Study burden and risks
Implantation of the Artiflex Presbyopic IOL may result in an improved near,
intermediate, and far visual acuity, and thereby in a complete spectacle
independency. However, as mentioned previously, the implantation may be
accompanied by lens-related complications like contrast sensitivity loss and
the presence of dysphotopsia or photic phenomena. The loss of contrast
sensitivity is related to the fact that a multifocal optic divides the incoming
light over two or more focal points. Especially under mesopic conditions, this
loss of contrast sensitivity can become clinically relevant. Photic phenomena
may disturb vision or hinder the subject in normal functioning and are the
leading cause for dissatisfaction after multifocal IOL implantation. In the
worst case, the presence of certain complications might require a secondary
surgical intervention, to for example exchange the lens for a different model.
By careful selection, according to the exclusion criteria, most complications
should be avoided. The regular postoperative examination should result in early
detection, and thus treatment, of potential complications. If subject selection
and postoperative monitoring are performed as per protocol, benefits to the
subject outweigh the risks of participation in the clinical trial.
Schweitzerlaan 15
Groningen 9728 NR
NL
Schweitzerlaan 15
Groningen 9728 NR
NL
Listed location countries
Age
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
•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
•Subjects with a distance corrected near visual acuity of better than 20/60 or
0.48 LogMAR.
•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
measured from the 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
•Aged under 18
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04632784 |
| CCMO | NL76222.000.21 |