Clinical Trial With Artiflex Presbyopic

Sponsor

Ophtec BV (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04632784

Collaborator

(none)

140

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic intraocular lens.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Ametropia Refractive Errors Myopia Hyperopia	Device: Artiflex Presbyopic implantation	N/A

Detailed Description

The study is a prospective, open-label, single-arm, and multicentre clinical investigation with three years of follow-up. Artiflex Presbyopic 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. The results of this study will be used for CE-approval and registration as well as marketing purposes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Multicentre Clinical Trial With the Artiflex Presbyopic, an Iris-fixated Multifocal Intraocular Lens for the Correction of Presbyopia in Phakic Eyes

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artiflex Presbyopic About 125 - 140 subjects will receive the Artiflex Presbyopic lens bilaterally and will be followed for a period of 3 years.	Device: Artiflex Presbyopic implantation Implantation of iris-fixated multifocal Artiflex Presbyopic IOL

Arm

Intervention/Treatment

Experimental: Artiflex Presbyopic

About 125 - 140 subjects will receive the Artiflex Presbyopic lens bilaterally and will be followed for a period of 3 years.

Device: Artiflex Presbyopic implantation

Implantation of iris-fixated multifocal Artiflex Presbyopic IOL

Outcome Measures

Primary Outcome Measures

Improvement in monocular and binocular uncorrected near visual acuity (UNVA) [3 years]
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) [3 years]
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) [3 years]
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) [3 years]
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) [3 years]
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) [3 years]
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) [3 years]
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 [3 years]
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) [3 years]
The absolute difference between the actually obtained MRSE and the target MRSE
Predictability of the manifest refraction spherical equivalent (MRSE) [3 years]
The percentage of eyes that achieves a MRSE of less than or equal to 0.5 D difference between the actual and target MRSE
Predictability of the manifest refraction spherical equivalent (MRSE) [3 years]
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) [3 years]
Mean change in MRSE between visits as determined by a paired analysis
Stability of manifest refraction spherical equivalent (MRSE) [3 years]
The percentage of eyes that achieves a change in MRSE of less than or equal to 0.5 D between two consecutive refraction measurements
Stability of manifest refraction spherical equivalent (MRSE) [3 years]
The percentage of eyes that achieves a change in MRSE of less than or equal to 1.0 D between two consecutive refraction measurements
Evaluation of visual disturbances using a validated questionnaire [3 years]
Assessing the percentage of subjects who experience different visual disturbances, by means of questionnaire
Evaluation of visual disturbances using a validated questionnaire [3 years]
Assessing the occurrence of the different visual disturbances by means of questionnaire
Evaluation of visual disturbances using a validated questionnaire [3 years]
Assessing the severity of the different visual disturbances by means of questionnaire
Evaluation of visual disturbances using a validated questionnaire [3 years]
Assessing the bothersomeness of the different visual disturbances by means of questionnaire
Evaluation of visual disturbances using a validated questionnaire [3 years]
Assessing the time of onset of visual disturbances by means of questionnaire
Satisfaction questionnaire [3 years]
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 [3 years]
Comparison of the preoperative and postoperative endothelial cell density
Endothelial cell density [3 years]
Endothelial cell loss over time
Endothelial cell density [3 years]
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
Adverse event (AEs) / complication rates [3 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
A distance corrected near visual acuity of 20/60 or worse (0.48 LogMAR or higher)
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 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 the disease:

Preoperative ocular or systemic condition or medication use that would be expected to present an 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.
Preoperative subjective astigmatism exceeding 1.0 D
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 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
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