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临床试验/NCT04249492
NCT04249492已完成不适用

Multicentric Post-Market Clinical Follow-up (PMCF) Investigation to Determine Safety and Efficacy of a Hydrophobic EDOF Intraocular Lens (IOL) in Comparison to a Monofocal IOL

Beaver-Visitec International, Inc.24 个研究点 分布在 6 个国家目标入组 250 人开始时间: 2020年2月11日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
24
主要终点
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

详细描述

This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

The study will be carried out in up to five clinical centers in Europe and Asia.

The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.

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
Single (Participant)

盲法说明

Single-blind masking; Patient will not be informed which IOL model was implanted until end of the study.

入排标准

年龄范围
45 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Cataractous eyes with no comorbidity;
  • •Calculated IOL power is within the range of the study IOLs;
  • •Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes;
  • •Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
  • •Clear intraocular media other than cataract;
  • •Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • •Signed informed consent.

排除标准

  • •Age of patient < 45 years;
  • •Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
  • •Irregular astigmatism;
  • •Difficulty for cooperation (distance from their home, general health conditions);
  • •Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
  • •Subjects with AMD suspicious eyes as determined by OCT examination;
  • •Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
  • •Previous intraocular or corneal surgery;
  • •Traumatic cataract;
  • •History or presence of macular edema;
  • •Instability of keratometry or biometry measurements;
  • •Ocular hypertension or glaucoma;
  • •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
  • •Expected complicated surgery;
  • •Significant dry eye.

结局指标

主要结局

monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.

时间窗: 6 months (120-180 days) postoperative

No statistically significant difference between the two study groups on monocular CDVA at 4-6 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

次要结局

  • Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Contrast Sensitivity under mesopic light conditions and using a glare source(6 months (120-180 days) postoperative)
  • Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Binocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Defocus Curve(1 month (30-60 days) postoperative)
  • Binocular Defocus Curve(6 months (120-180 days) postoperative)
  • Binocular Contrast Sensitivity under photopic light conditions(6 months (120-180 days) postoperative)
  • Manifested refraction(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Contrast Sensitivity under mesopic light conditions(6 months (120-180 days) postoperative)
  • Halo and Glare Simulator(preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Aberrometry(preoperative, 6 months (120-180 days) postoperative)
  • Pupil Size under photopic light conditions(preoperative, 6 months (120-180 days) postoperative)
  • Pupil Size under mesopic light conditions(preoperative, 6 months (120-180 days) postoperative)
  • Fundus examination with dilated pupil(preoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Corneal status(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Signs of inflammation(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Pupillary block(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Retinal detachment(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Status of anterior and posterior capsule(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL decentration(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL tilt(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL discoloration(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL opacity(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Manifested refraction(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions(1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions(1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)
  • Binocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions(6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Monocular Defocus Curve(1 month (30-60 days) postoperative)
  • Binocular Defocus Curve(6 months (120-180 days) postoperative)
  • Binocular Contrast Sensitivity under photopic light conditions(6 months (120-180 days) postoperative)
  • Binocular Contrast Sensitivity under mesopic light conditions(6 months (120-180 days) postoperative)
  • Binocular Contrast Sensitivity under mesopic light conditions and using a glare source(6 months (120-180 days) postoperative)
  • Halo and Glare Simulator(preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017](preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Aberrometry(preoperative, 6 months (120-180 days) postoperative)
  • Pupil Size under photopic light conditions(preoperative, 6 months (120-180 days) postoperative)
  • Pupil Size under mesopic light conditions(preoperative, 6 months (120-180 days) postoperative)
  • Fundus examination with dilated pupil(preoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Corneal status(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Signs of inflammation(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Pupillary block(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Retinal detachment(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - Status of anterior and posterior capsule(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL decentration(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL tilt(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL discoloration(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)
  • Slitlamp examination - IOL opacity(Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (24)

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