Prospective multicentre clinical trial with the Artiflex Presbyopic, an iris-fixated multifocal intraocular lens for the correction of presbyopia in phakic eyes

Withdrawn

Conditions: ametropia
presbyopia
10047518

Registration Number: NL-OMON54294

Lead Sponsor: OPHTEC BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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