Evaluation of the Extended Depth of Focus After Bilateral Implantation of a Hydrophobic IOL With a New Optic Concept Based on a Combination of High Order Aberrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Corrected Distance Visual Acuity
研究概览
简要总结
This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch & Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation 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.
Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.
The device under investigation LuxSmart (Bausch & Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- •Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
- •Clear intraocular media other than cataract;
- •Dilated pupil size large enough to visualize IOL axis markings postoperatively
- •Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
- •Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.
排除标准
- •Age of patient <50 years;
- •Regular corneal astigmatism >1.5D (measured by an automatic keratometry) 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;
- •Instability of keratometry or biometry measurements;
- •Advanced or decompensated glaucoma;
- •Significant dry eye;
结局指标
主要结局
Corrected Distance Visual Acuity
时间窗: 6 months
Measurement of distance visual acuity is measured with 5 letters modified Snellen charts placed at 6 m distance with corrective glasses for each eye separately
次要结局
- Manifest refraction (sphere, cylinder, axis)(6 months)
- Monocular Uncorrected Distance Visual Acuity (UDVA)(6 months)
- Binocular Uncorrected Distance Visual Acuity (UDVA)(6 months)
- Monocular Corrected Distance Visual Acuity (CDVA)(6 months)
- Binocular Corrected Distance Visual Acuity (CDVA)(6 months)
- Monocular Uncorrected Intermediate Visual Acuity (UIVA)(6 months)
- Binocular Uncorrected Intermediate Visual Acuity (UIVA)(6 months)
- Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)(6 months)
- Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)(6 months)
- Monocular Defocus Curve(6 months)
- Monocular Contrast Sensitivity under photopic and mesopic conditions(6 months)
- Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score(6 months)
- Overall Spectacle independence(6 months)
研究者
Dr. Pavel Stodulka
Chief Eye Surgeon
Gemini Eye Clinic