Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Corrected Distance Visual Acuity at 6m (CDVA) - monocular
研究概览
简要总结
This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symfony® IOL after phaco-emulsification cataract surgery.
详细描述
With the advent of a new intraocular lens (IOL) materials, technologies and advanced optics, higher spectacle independence after surgery is now possible.
Multifocal IOLs work by splitting light into different foci, which is known to generate photic effects. Trifocal optics, which have been available on the European market since 2010, offer spectacle independence in most cases. Typically, visual acuity is maintained throughout the whole range of vision from distance to near vision, and general patient satisfaction has proven that trifocal IOLs are well tolerated by patients.
Patients having irregular corneal astigmatism, large pupils and weak zonules were considered unsuitable candidates for multifocal IOLs, while patients who aim for spectacle independence and with low pre-operative regular astigmatism were considered to be good candidates.
The Fine Vision IOL (PhysIOL®; Liège, Belgium) is a diffractive trifocal IOL that provides an intermediate focus at 1.75 D and a near focus at 3.5 D (both at the IOL plane). This corresponds to a nominal intermediate add of approximately +1,15 D and near add of about 2,25 D at the corneal plane, depending on the geometry of the patient's eye. This intermediate focal point is expected to improve patient satisfaction relative to bifocal IOLs, since bifocal IOLs have a greater drop off in visual acuity (VA) in the intermediate range. There is a concern that the addition of a third focal point may increase halos, However, a relatively small percentage of energy is dedicated to intermediate vision when compared to distance and near vision. The trifocal diffractive structure asymmetrically directs incident light to distant (50%) intermediate (20%) and near (30%) focal points, independent of pupil diameter (up to 4,5 mm).
The FineVision is an aspheric trifocal IOL composed of 25% hydrophilic acrylic material with a blue light and ultraviolet light blocker. It has a total diameter of 10,75 mm and an optic body diameter of 6,15 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataract patients requesting independence from spectacles
- •Potential visual acuity of 0.0 logMar
排除标准
- •Unrealistic expectations (sharp clear vision is the main concern of the patient)
- •Ocular pathology besides cataract (glaucoma, macular degeneration, retinopathies, corneal opacities, corneal guttata.. etc.)
- •Previous refractive surgery
- •Expected pathology after surgery (p.e. uveitis, diabetic retinopathy, PEX)
- •Preoperative corneal astigmatism of > 1.0 D
- •Any intraocular or postoperative complication
- •Dry eye disease
- •History of ocular trauma
结局指标
主要结局
Corrected Distance Visual Acuity at 6m (CDVA) - monocular
时间窗: 3 months postoperative
CDVA is measured with ETDRS charts placed in 6m distance with best aided corrective glasses according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
次要结局
- Uncorrected Near Visual Acuity at 35cm (UNVA)(3 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular(3 months postoperative)
- Defocus Curve(3 months postoperative)
- Contrast Sensitivity(3 months postoperative)
- National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)(3 months postoperative)
- Manifest Refraction(3 months postoperative)
- Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular(3 months postoperative)
- Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular(3 months postoperative)