Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Distance corrected visual acuity for intermediate distance
研究概览
简要总结
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
详细描述
Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.
Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.
The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.
The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.
The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related bilateral cataract
- •Age 21 or older
- •Visual acuity > 0.05
- •For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
- •Written informed consent prior to surgery
排除标准
- •Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- •Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- •Corneal decompensation or corneal endothelial cell insufficiency
- •Irregular astigmatism on corneal tomography
- •Pronounced dry eye disease
- •Previous ocular surgery or trauma
- •Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
结局指标
主要结局
Distance corrected visual acuity for intermediate distance
时间窗: 6 months
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
次要结局
- Uncorrected visual acuity for intermediate distance(6 months)
- Uncorrected and distance corrected visual acuity for far distance(6 months)
- Uncorrected and distance corrected visual acuity for near distance(6 months)
- Defocus curve assessment(6 months)
- Halometry(6 months)
- Contrast sensitivity(6 months)
- Subjective rating of dysphotopsia(6 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery