ACTRN12617000708358进行中（未招募）未知
Clinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoration in Adults with Cataract
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- PowerVision
- 入组人数
- 96
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. At least 50 years of age;
- •2. Willing and able to comply with schedule for follow-up visits;
- •3. Able to read and understand the Informed Consent Form and Patient Information materials;
- •4. Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction
- •5. Corrected distance visual acuity is equal to or worse than 20/40 either with or without a glare source present OR presence of visually significant lens opacity;
- •6. Predicted corrected distance visual acuity in both eyes to be 20/32 or better after cataract removal and IOL implantation as determined by potential acuity meter (PAM) or other potential vision tests;
- •7. Less than or equal to 1.0 diopter (D) of preoperative or predicted post-operative corneal astigmatism;
- •8. Clear intraocular media other than cataract;
- •9. Preoperative central endothelial cell density of 2200 cells/mm2 or more;
- •10. Eligible for LASIK procedure or other corneal refraction correction procedure;
- •11. Willing to wear contact lenses and physically capable of wearing them per
- •investigator examination
- •12. Able to undergo second eye surgery within 14 days after the first eye surgery.
排除标准
- •1. Subject is a member of a vulnerable population as defined in ISO 14155;
- •2. Current use of medications that may affect accommodation;
- •3. Current or historic use of systemic medications that may confound the outcome or increase the risk to the subject;
- •4. Sensitivity to planned study medications;
- •5. Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes;
- •6. Has systemic disease that could increase the operative risk or confound the outcome;
- •7. Ocular conditions that may predispose for future complications (e.g. anterior segment pathology including potentially occludable angles, corneal dystrophy, ocular inflammation);
- •8. Monocular patient or significant permanent visual function loss in one eye;
- •9. Previous refractive, intraocular or corneal surgery in either eye;
- •10. Diagnosed degenerative visual disorders that are predicted to cause future corrected distance visual acuity worse than 20/32;
- •11. Conditions that increase the risk of zonular rupture during procedure;
- •12. Simultaneous participation in other ophthalmic drug or device clinical trial;
- •13. Baseline dilated pupil size less than 8 mm in diameter;
- •14. Anterior Chamber Depth (ACD) less than 2.8 mm, based on IOL Master;
- •15. Grade 4 cataract in either eye, as assessed per the Quick Reference Guide (QRG)-8 published by the American Optometric Association;
- •16. Subject has any other condition(s), disease(s) or habit(s) that would interfere with completion of the study and follow-up visits, increase the risk(s) of the cataract and/or IOL procedure, or in the physician’s judgement, would interfere with compliance to the study or adversely impact study outcomes.
- •17. Subject randomized to AIOL with ocular dimensions not within range of manufacturer’s fitting algorithm.
- •Intraoperative Exclusion Criteria
- •18. Do not have an intact capsulorhexis and posterior capsule at the time of cataract
- •extraction and lens implantation;
- •19. Floppy/weak zonules, incomplete zonules or zonular rupture during cataract
- •extraction;
- •20. Posterior capsules that are found to be thin, brittle or fibrosed;
- •21. Decentered capsulorhexis of >1.0 mm in relation to the limbus;
- •22. Posterior capsular opacity observed after cataract extraction;
- •23. Complicated cataract surgery that prevents attempted implantation of the (A)IOL.
- •Additional Intraoperative Exclusion Criteria for the FluidVision AIOL
- •24. Unable to attain and maintain a dilated pupil size =7 mm in diameter;
- •25. Capsulorhexis size of less than 6.0 mm or greater than 6.5 mm.
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