NL-OMON46484已完成4 期
Post-Market Clinical Investigation of the Clareon® IOL - Niet van toepassing
Alcon Laboratories0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adults, 22 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
- •2. Able to comprehend and willing to sign an IRB/IEC approved statement of informed consent and complete all required post-implantation visits
- •3. Planned small incision cataract removal surgery
- •4. Calculated lens power is within the available range (see Table 11-1 for the available range of lens powers for this study)
- •5. Subjects for whom postoperative emmetropia is planned (defined as 0.00± 0.50 D spherical equivalent) in both eyes
- •6. Preoperative BCDVA worse than 0.2 logMAR in at least one eye
- •Potential post-implantation visual acuity of 0.2 logMAR or better in both eyes based on Investigator expert medical opinion
排除标准
- •1. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than Nd:YAG capsulotomy)
- •2. Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of the subjects* participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions)
- •3. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial, stromal, or endothelial dystrophy), inflammation or edema per the Investigator*s expert medical opinion
- •(Note: Conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded.)
- •4. Amblyopia
- •5. Previous corneal transplant
- •6. Extremely shallow anterior chamber (* 2.5 mm), not due to swollen cataract
- •7. Any recurrent severe anterior or posterior segment inflammation of any etiology, and or history of any disease producing an intraocular inflammatory reaction
- •8. Rubella, congenital, traumatic, or complicated cataracts
- •9. Ocular conditions where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology)
- •10. Iris neovascularization
- •11. Glaucoma (uncontrolled or controlled with medication)
- •12. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha1A adrenoceptor (eg, Flomax (tamsulosin HCL), Hytrin, or Cardura) that in the opinion of the Investigator would potentially require mechanical or surgical manipulation to enlarge the pupil
- •13. Subjects with diagnosed degenerative eye disorders, such as but not limited to, pseudoexfoliation
- •14. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes.
- •Note: Including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration
- •15. Optic nerve atrophy
- •16. Subjects who are expected to require retinal laser treatment
- •17. Subjects with diagnosed congenital ocular disorders, such as but not limited to, aniridia or microphthalmia
- •18. Pregnancy or lactation current or planned during the course of the study
- •19. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
- •20. Any other additional procedures during the cataract removal and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior rupture, with vitreous loss, zonular dehiscence that may make the IOL implant less stable
- •21. Uncontrolled intraocular pressure
- •22. Significant anterior chamber bleeding
- •23. Excessive iris mobility
- •24. Mechanical or surgical intervention required to manipulate the pupil
- •Note: Pupil size must be 4.5mm or larger just prior to implantation
- •25. Any capsulorhexis other than continuous curvilinear capsulorhexis (eg, no anterior radial inconsistencies in the capsulorhexis such as anterior capsular tears or any areas of *can-opener* capsulotomy)
- •26. Unrecognized (pre-existing but discovered during surgery) ocular conditions or complications in which the IOL positio
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