Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Binocular Distance-corrected Near (40 cm) Visual Acuity.
研究概览
简要总结
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
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
- None
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
- •Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
- •Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
排除标准
- •Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- •Clinically significant corneal dystrophy
- •History of chronic intraocular inflammation.
- •History of retinal detachment.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Previous intraocular surgery.
- •Previous refractive surgery.
- •Previous keratoplasty
- •Severe dry eye
- •Pupil abnormalities
- •Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
- •Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
结局指标
主要结局
Binocular Distance-corrected Near (40 cm) Visual Acuity.
时间窗: 3 months
Visual acuity with correction (glasses) measured at 40 cm.
Reduction of Manifest Cylinder (Diopters).
时间窗: 3 months
次要结局
- Uncorrected Intermediate (66 cm) Visual Acuity(3 months)
- Uncorrected Near (40 cm) Visual Acuity(3 months)
- Uncorrected (4 m) Visual Acuity(3 months)
- Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)(3 months)
- Patient Reported Spectacle Independence Questionnaire(3 months)