DRKS00011600已完成未知
Evaluation of Clinical Acceptability of the IC-8 Intraocular Lens
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Minimum 18 years of age
- •2. Cataract for which phacoemulsification or femtosecond-assisted extraction and posterior
- •chamber IOL implantation has been planned for each eye
- •3. Planned procedure in the eye to be implanted with the IC-8 IOL within four to six weeks
- •from the initial procedure of the eye implanted with an aspheric monofocal IOL
- •4. Best corrected distance visual acuity (CDVA) following cataract removal and IOL implantation
- •projected to be 0.8 (Snellen 20/25) or better as determined by diagnostic testing or
- •investigator’s medical judgment
- •5. Preoperative anterior chamber depth exclusive of corneal thickness preoperatively of
- •2.50 to 4.75 mm
- •6. Clear intraocular media other than cataract
- •7. Availability, willingness, ability and sufficient cognitive awareness to comply with
- •examination procedures and study visits
- •8. Signed informed consent
排除标准
- •1. Requiring an intraocular lens outside the spherical power range of +16.0 to +27.0 diopters
- •2. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil
- •abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked
- •microphthalmos
- •3. Previous corneal or intraocular surgery, except pterygium surgery that may be allowed
- •based on clinical evaluation
- •4. Preoperative corneal astigmatism > 1.75 diopters as determined by corneal topography
- •or keratometry in either eye. Or irregular corneal astigmatism
- •5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or
- •diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal
- •disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse
- •during the study
- •6. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis,
- •rubeosis iridis, etc.)
- •7. Glaucoma suspect, uncontrolled ocular hypertension or glaucomatous changes in the
- •retina or visual field
- •8. Congenital bilateral cataracts
- •9. Conditions associated with increased risk of zonular rupture, including capsular or
- •zonular abnormalities that may lead to IOL decentration (e.g. pseudoexfoliation, trauma,
- •or posterior capsule defects).
- •10. Known ocular disease or pathology that may affect visual acuity or that may require
- •surgical intervention during the course of the study (cystoid macular edema, diabetic
- •retinopathy, etc.)
- •11. Use of systemic or ocular medications that may affect vision, or anti-psychotic and
- •antidepressant medication within the last 6 months
- •12. Prior, current, or anticipated use during the course of the 6 month study of tamsulosin or
- •silodosin (alpha-adrenergic antagonist medications: e.g., Flomax, Flomaxtra, Rapaflo)
- •likely to cause poor dilation or lack of adequate iris-structure to perform standard
- •cataract surgery
- •13. Poorly-controlled or insulin dependent diabetes
- •14. Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of
- •the investigator, increase the operative risk or confound the outcome(s) of the study
- •(e.g., immunocompromised, connective tissue disease, hypertension, etc.)
- •15. Diagnosis of dry-eye or dependency on ocular lubricating drops to maintain eye comfort
- •or adequate vision
- •16. Patient is pregnant, plans to become pregnant, is lactating or has another condition
- •associated with the fluctuation of hormones that could lead to refractive changes
- •17. Concurrent participation or participation during 30 days prior to preoperative visit in any
- •other or clinical trial
研究者
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