Clinical Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Toric IOL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
研究概览
简要总结
Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425)
详细描述
This is a prospective, controlled, single-surgeon, single-center clinical study, whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. The study is aimed to compare visual acuity outcomes the FineVision POD FT IOL to data obtained in a similar study by the same principal investigator on the trifocal FineVision POD F IOL (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425), whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the FineVision POD FT IOL in both eyes or, in case the corneal astigmatism in one of the two eyes of the same patient is too small to implant a toric lens, the FineVision POD F IOL will be implanted in this eye (both lenses: PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD FT and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is that that the POD FT IOL is the toric version of the POD F IOL. 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 11 study visits (1 preoperative, 2 operative and 8 postoperative) over a period of 24 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 6 months follow up visit and secondary endpoint data will be collected at the 1 Day, 1 Week, 1 month, 6, 12 and 24 months postoperative visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
- •Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) in one or both eyes;
- •Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- •Clear intraocular media other than cataract;
- •Calculated IOL power is within the range of the study IOLs;
- •Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- •Willing and able to conform to the study requirements.
排除标准
- •Regular corneal astigmatism <0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes
- •Irregular astigmatism;
- •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;
- •Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- •Concurrent or previous (within 30 days) participation in another drug or device investigation;
- •Instability of keratometry or biometry measurements;
- •Ocular hypertension or glaucoma;
- •Significant dry eye;
- •Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
研究组 & 干预措施
POD FT IOL Implantation experimental
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.
干预措施: IOL implantation experimental (Device)
结局指标
主要结局
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
时间窗: 6 months (120-180 days) postoperative
Monocular visual acuity outcomes on CDVA under photopic light conditions are statistically non-inferior to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425).
次要结局
- Uncorrected Distance Visual Acuity (UDVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular(1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Uncorrected Near Visual Acuity at 35cm (UNVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular(1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Manifested refraction(Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Corrected Distance Visual Acuity (CDVA) - monocular(Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Corrected Distance Visual Acuity (CDVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular(1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Pupil Size(6 months postoperative)
- Uncorrected Distance Visual Acuity (UDVA) - monocular(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular(1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular mesopic(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Defocus Curve(6 months postoperative)
- Binocular Contrast Sensitivity under photopic light conditions(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - Pupillary block(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - Status of anterior and posterior capsule(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - Corneal Status(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular mesopic.(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Binocular Contrast Sensitivity under mesopic light conditions and using a glare source(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Photograph of IOL with dilated pupil to asses IOL rotation(OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - IOL decentration(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Binocular Contrast Sensitivity under mesopic light conditions(6 months postoperative, 12 months postoperative, 24 months postoperative)
- Patient reported outcomes(6 months postoperative, 12 months postoperative)
- Fundus examination with dilated pupil(Pre-OP, 1 month postoperative, 12 months postoperative)
- Slitlamp examination - Signs of inflammation(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - Retinal detachment(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - IOL tilt(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - IOL discoloration(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)
- Slitlamp examination - IOL opacity(Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative)