Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 243
- 试验地点
- 19
- 主要终点
- Monocular DCIVA at 66cm for First Eyes
研究概览
简要总结
Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 22 years of age;
- •Bilateral cataracts for which posterior chamber IOL implantation has been planned;
- •Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;
- •Potential for postoperative BCDVA of 20/30 Snellen or better;
- •Corneal astigmatism:
- •Normal corneal topography;
- •≤ 1.0 D of preoperative keratometric astigmatism;
- •Clear intraocular media other than cataract;
- •Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures;
- •Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
- •Ability to understand and respond to a questionnaire in English.
排除标准
- •Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;
- •Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- •Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
- •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
- •Irregular corneal astigmatism;
- •Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures);
- •History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs;
- •Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
- •Use of systemic or ocular medications that may affect vision;
- •Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
- •Poorly controlled diabetes;
- •Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable;
- •Known ocular disease or pathology that, in the opinion of the investigator:
- •may affect visual acuity;
- •may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.);
- •may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.);
- •Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes;
- •Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial;
- •Desire for monovision correction.
研究组 & 干预措施
Control Lens Device
Control IOL Model ZCB00/DCB00
干预措施: control IOL Model ZCB00/DCB00 (Device)
Investigational Lens Device
Investigational IOL Model DEN00V
干预措施: investigational IOL Model DEN00V (Device)
结局指标
主要结局
Monocular DCIVA at 66cm for First Eyes
时间窗: 6 Months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular BCDVA at 4 Meters for First Eyes
时间窗: 6 Months
Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular Depth of Focus for First Eyes
时间窗: 6 Months
Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.
次要结局
未报告次要终点