ametropia presbyopia
Conditions
Interventions
Subjects receive the Artiflex Presbyopic multifocal IOL in both eyes. Surgical
procedure and medication regime are standard for intraocular lens implantation.
Sponsors
OPHTEC BV
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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. 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 outcomes
Primary
| Measure | 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 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 MRS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed