DRKS00005696暂停未知
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens - AIOL-2009-1
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 115
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
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •1.Patients must be eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction.
- •2.Patients should have a best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester)
- •3.Patients predicted best corrected distance visual acuity must be 20/40 or better after cataract removal and AIOL implantation as determined by potential acuity meter (PAM) or other potential vision tests or surgeon estimation on both eyes.
- •4.Patients must have =1.0 D of preoperative keratometric astigmatism.
- •5.Patients must have clear intraocular media other than cataract.
- •6.Patients must have a preoperative endothelial cell density of 2200 cells/mm2 or more.
- •7.Patients must be at least 50 years of age.
- •8.Patients must be willing and able to comply with schedule for follow-up visits for thirty six months after surgery.
- •9.Patients must have a calculated AIOL power within the range of the investigational device;
- •10.Patients must provide written informed consent.
排除标准
- •1.Patients must not be taking medications that may affect accommodation (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents).
- •2.Patients must not have systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes).
- •3.Patients must not have systemic medications that may confound the outcome or increase the risk to the subject i.e tamsulosin hydrochloride (Flomax) or other medications with similar side effects.
- •4.Patients must not have ocular conditions that may predispose for future complications (e.g. anterior segment pathology including glaucoma or potentially occludable angles, corneal dystrophy, ocular inflammation, poor pupil dilation).
- •5.Patients must not have previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
- •6.Patients must not be pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- •7.Patients must not have degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
- •8.Patients must not have conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome).
- •9.Patients must not have sensitivity to planned study medications.
- •10.Patients must not be simultaneously participating in other ophthalmic drug or device clinical trial.
- •11.Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract extraction and lens implantation.
- •12.Patients who have floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction.
- •13.Patients who have a capsulorhexis size of <5.5 mm or >6.0 mm.
- •14.Patients who have a decentered capsulorhexis of >1.0 mm in relation to the limbus.
- •15.Patients with posterior capsular opacity observed after cataract extraction.
- •16.Patients with complicated cataract surgery or damage to AIOL that prevents implantation of the AIOL (e.g. pupillary constriction, poor visibility due to corneal edema).
研究者
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