NL-OMON54294撤回不适用
Prospective multicentre clinical trial with the Artiflex Presbyopic, an iris-fixated multifocal intraocular lens for the correction of presbyopia in phakic eyes - Clinical Trial With Artiflex Presbyopic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- OPHTEC BV
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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)
- •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
- •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
研究者
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