NCT07471295招募中4 期
Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Refractive predictability
研究概览
简要总结
The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older;
- •Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
- •Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;
- •Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
- •Signed informed consent form;
- •Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;
- •Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);
- •Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;
- •Clear intraocular media other than cataract.
排除标准
- •Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
- •Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
- •Traumatic cataract;
- •Pregnancy or lactation;
- •Concurrent participation in another drug or device investigation within the last 30 days;
- •Irregular astigmatism;
- •Instability of keratometry or biometry measurements;
- •Subjects wearing contact lenses as standard vision aid;
- •Abnormal pupil;
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);
- •History of concurrent intraocular inflammation;
- •Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);
- •History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;
- •Pseudoexfoliation syndrome (according to investigator judgement);
- •Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
- •All kind of infections (acute ocular disease, external / internal infection, systemic infection);
- •Monophthalmic patient;
- •Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease
- •Patient expected to require retinal laser treatment before the end of the last follow-up examination;
- •Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination;
- •Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)
- •In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day
研究组 & 干预措施
Unilateral or bilateral implantation of investigational device
Experimental
干预措施: Monofocal toric IOL (Device)
结局指标
主要结局
Refractive predictability
时间窗: From preoperative visit to the final postoperative visit at twelve months
Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D
次要结局
- Stability of IOL axis orientation(Between 30 to 60 days and 120 to 180 days)
- Binocular defocus curve on subjects implanted binocularly(12-Months Postoperatively)
- Intraocular Pressure(12-Months Postoperatively)
- Assessment of subject satisfaction, patient reported outcomes, and spectacle independence(12-Months Postoperatively)
- Monocular Uncorrected Distance Visual Acuity (UDVA)(12-Month Postoperative)
- Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better(12-Months Postoperatively)
- IOL observations(12-Months Postoperatively)
- Refractive outcomes(From preoperative visit to the final postoperative visit at twelve months)
- Refractive predictability(From preoperative visit to the final postoperative visit at twelve months)
- Reduction in cylindrical power(From preoperative visit to the final postoperative visit at twelve months)
- IOL Rotation(From preoperative visit to the final postoperative visit at twelve months)
- Axis Misalignment(From baseline to postoperative visit 120-180 days)
- Monocular Best-Corrected Distance Visual Acuity (CDVA)(12-Months Postoperatively)
- Monocular Uncorrected Intermediate Visual Acuity (UIVA)(12-Months Postoperatively)
- Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)(12-Months Postoperatively)
- Monocular (1st eye implantations) defocus curve(12-Months Postoperatively)
研究者
研究点 (6)
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