Prospective, randomized, double-masked, multicenter post-market clinical investigation comparing two dispersive viscosurgical devices - PROMIZ

Carl Zeiss Meditec AG0 个研究点目标入组 270 人开始时间: 2022年6月15日最近更新: 2024年8月19日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: Carl Zeiss Meditec AG
入组人数: 270

研究概览研究设计入排标准研究者记录与标识符相似试验

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: Randomized controlled study
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 one（—）
性别: All

入选标准

•1. Adult subject;
•2. Subject has clear intraocular media excluding the presence of cataract;
•3. Subject is scheduled for uncomplicated age-related cataract removal by phacoemulsification and IOL implantation in the capsular bag with sole administration of either investigational or control device as per randomization scheme;
•4. Subject is informed of the requirements of the Clinical Investigational Plan and available, able and willing to comply with the visit schedule and planned procedures;
•5. Subject has given his/her written informed consent.

排除标准

•The subject’s contralateral eye is already participating in this study;
•2. Subject has previously undergone or is scheduled for cataract surgery to the contralateral eye within 14 days of the study eye surgery;
•3. Mono-ophthalmic subject (e.g., single eye status, amblyopia, strabism, microphthalmos);
•4. Subject has had previous ocular trauma or ocular surgery;
•5. Subject is scheduled to undergo other combined intraocular procedures in the study eye during the cataract/IOL implantation surgery or during the course of the investigation;
•6. Planned Femtosecond Laser cataract surgery;
•7. Subject with medically controlled ocular hypertension (regardless of IOP value) or elevated intraocular pressure at baseline > 24 mmHg, uncontrolled glaucoma, or glaucomatous changes;
•8. Subject has a history of chronic, recurrent or acute ocular infection or inflammation;
•9. Subject has a corneal abnormality or condition preventing reliable specular microscopy (e.g., significant scarring, stromal, epithelial or endothelial dystrophies, edema, irregularity, keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia);
•10. Subject has reduced corneal endothelium (e.g., Fuch’s dystrophy) or endothelial cell count (ECC) lower than 2000 cells/mm2 on average preoperatively;
•11. Subject has an anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis, pseudoexfoliation syndrome, synechiae, fibrin, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation);
•12. Subject has a pupil abnormality (e.g., non-reactive, fixed pupils, abnormally shaped pupils, aniridia, anisocoria, pathologic miosis);
•13. Subject has had previous retinal detachment or is predisposed to postoperative retinal complications requiring treatment;
•14. Subject has an acute or chronic illness or uncontrolled disease (systemic, ocular or congenital) that would increase the operative risk or confound the outcome(s) of the investigation (e.g., severe dry eye, rubella, congenital or complicated cataracts, changes of the retina, retinal vessel disease, poorly controlled diabetes associated with any changes of the retina, macular degeneration, cystoid macular edema, immunocompromised or healing-process-compromised subjects, Marfan’s Syndrome, connective tissue disease, clinically significant atopic disease, active cancer treatment, mental illness, dementia);
•15. Subjects is using or is expected to use systemic or ocular medications during the course of the study that may confound the outcome of the investigation or increase the risk to the subject according to the Investigator’s opinion, including, but not limited to, anti-metabolites (e.g., Tamsulosin Hydrochloride [Flomax] or silodosin or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g., small pupil/floppy iris syndrome]);
•16. Subject is using or is expected to use systemic steroids during the course of the study and/or is a known steroid responder;
•17. Subject has an allergy to anesthetics, other peri-/postoperative medications, or the investigational and/or control device;
•18. Subject has a known hypersensitivity to Sodium Hyaluronate;
•19. Subject may require the use of hyaluronidase during cataract surgery;
•20. Investigational or control device is not a suitable device for the subject for

研究者

发起方

Carl Zeiss Meditec AG

相似试验

进行中（未招募）

1 期

EUCTR2015-001528-41-PLAerie Pharmaceuticals Ireland Ltd.472

进行中（未招募）

1 期

A prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03% / timolol 0.5% Opthalmic Solution) in subjects with elevated intraocular pressure (MERCURY 3)Open angle glaucoma (OAG) or ocular hypertension (OHT)

EUCTR2015-001528-41-HUAerie Pharmaceuticals Ireland Ltd.472

进行中（未招募）

1 期

EUCTR2015-001528-41-LVAerie Pharmaceuticals Ireland Ltd.472

进行中（未招募）

1 期

EUCTR2015-001528-41-ATAerie Pharmaceuticals Ireland Ltd.440

进行中（未招募）

1 期

A prospective, double-masked, randomized, multicenter, active-controlled,parallel-group, 6-month study assessing the safety and ocular hypotensiveefficacy of PG324 Ophthalmic Solution compared to GANFORT®(bimatoprost 0.03% / timolol 0.5% Opthalmic Solution) in subjects withelevated intraocular pressure (MERCURY 3)open angle glaucoma (OAG) or ocular hypertension (OHT)MedDRA version: 20.1Level: LLTClassification code 10043273Term: Tension ocular increasedSystem Organ Class: 100000004848

EUCTR2015-001528-41-ITAERIE PHARMACEUTICALS IRELAND LTD.440