NCT00774228已完成不适用
Clinical Evaluation of the I-ZIP® Ocular Bandage as a Protective Ocular Bandage in Subjects Undergoing Clear Corneal Cataract Surgery With IOL Implantation: A Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Device remains localized over corneal incision
研究概览
简要总结
To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation using internal calipers.
排除标准
- •Any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative NRPS
- •Previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/IOL implantation surgery
- •Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator
- •Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations
- •Subject is currently receiving antineoplastic therapy
- •Use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery.
- •Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR), proliferative diabetic retinopathy (PDR) or compromised macular function
结局指标
主要结局
Device remains localized over corneal incision
时间窗: 24 hours post operative
次要结局
- Adverse ocular events(30 days post operative)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The use of I-ZIP® Adherent Ocular Bandage to help cataract surgery incisions seal more effectivelyEndophthalmitis/cataract surgeryEye DiseasesDisorders of globeISRCTN64880258Royal Berkshire NHS Foundation Trust (UK)50
已完成
不适用
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma SubjectsPrimary Open Angle Glaucoma (POAG)NCT01517477Glaukos Corporation119
已完成
3 期
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%Open-Angle GlaucomaOcular HypertensionNCT01297920Alcon Research1,062
已完成
不适用
Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")OphthalmologyPhotorefractive Keratectomy ("PRK")Laser Assisted SurgeryRefractive SurgeryNCT03938883Eyegate Pharmaceuticals, Inc.250
已完成
3 期
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS PlusCataractNCT00333268Alcon Research369