Clinical Investigation of OMEGA Gemini Capsule, Model Gemini Capsule 3 Rev 2 in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
研究概览
简要总结
This study is a prospective, observational, randomized, controlled, paired eye, subject-masked design.
详细描述
Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini 3 with an approved monofocal or Toric intraocular lens. Fellow eyes will receive an approved monofocal or Toric IOL (no Omega capsule).
Eyes randomized to receive one of the Gemini capsules (both models) will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.
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
- Single (Participant)
盲法说明
Subjects will be masked to which eye receives the study device
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 years of age or older at the time of surgery diagnosed with bilateral cataracts
- •Able to understand and sign an informed consent
- •Willing and able to complete all study visits and assessments required for the study
- •Calculated lens power within the available range
- •Corrected distance visual acuity is equal to or worse than 20/40 in each eye with or without a glare source present
- •Bilateral cataracts eligible for extraction by phacoemulsification and capsular bag fixated IOL implantation
- •Potential postop visual acuity of 20/25 or better in the judgment of the surgeon
- •Preoperative corneal astigmatism of 4.0 D or less with normal corneal topography
- •Clear intraocular media other than cataract
- •Preop endothelial cell density of 2000 cells/mm2 or more
排除标准
- •Subject's best corrected vision is light perception or no light perception in either eye
- •Cataract opacification preventing adequate Binocular Indirect Ophthalmoscopic retinal and macular examination.
- •Orbital abnormalities, such as thyroid related orbitopathy, causing significant exophthalmos.
- •Eyelid abnormalities causing lagophthalmos.
- •Significant anterior blepharitis or meibomian gland dysfunction
- •Corneal abnormalities or conditions, other than regular topographic corneal astigmatism
- •Krukenburg's spindle (linear pigmentary deposits on the corneal endothelium)
- •Abnormalities of the iris including trans-illumination defects
- •Pupil abnormalities (abnormally shaped, fixed or non-reactive)
- •Pharmacologic dilation less than 7 mm
- •Axial length <22.5mm
- •Lens thickness <4.1 mm
- •Anterior chamber depth >2.8mm
- •Extremely shallow anterior chamber <2.0mm
- •Prior ocular surgery
- •Epiretinal membrane
- •Macular edema
- •Retinal tears including operculated holes
- •Amblyopia
- •Glaucoma of any kind
- •Pseudoexfoliation syndrome
- •History of uveitis/iritis
- •Diabetic retinopathy
- •Acute, chronic or uncontrolled systemic or ocular disease that may confound the results of the study (including rheumatologic conditions such as Rheumatoid arthritis, ankylosing spondyliltis, Sjögren's syndrome, and neurologic conditions such as optic neuritis or multiple sclerosis).
- •Prior or anticipated use of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) or similar medications
- •Average Keratometry <38D or > 48D by topography
- •Any pathology of the zonules including evidence of zonular weakness, zonular instability, zonular damage, or coloboma effecting zonules.
- •History of ocular trauma
- •Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes
结局指标
主要结局
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
时间窗: 6 month Postop Visit
Via dilated slit lamp examination subjects will be assessed for anterior and posterior Via dilated slit lamp examination subjects will be assessed for anterior and posterior fusion of the IOL to the capsular bag with a dichotomous "Yes/No" response.
次要结局
未报告次要终点