CTRI/2023/11/060182尚未招募4 期
A prospective, open-label, single-arm clinical study to evaluate the performance & safety of Eyevisc 2.4% OVD in patient undergoing cataract surgery - NI
Biotech Ophthalmics Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Unilateral/Bilateral
- •2) Age = 45 year or greater.
- •3) Cataract for which phacoemulsification extraction and posterior
- •chamber IOL implantation was planned in at least one eye of the
- •patient. 4) Clear intraocular media other than cataract.
- •5) Signed informed consent. 6) Patient who are willing to attend all the regular follow-up
- •examinations as per the study schedule.
- •7) Patients with Grade I to III cataract and used OVDs
- •8) Patients that have healthy eyes excluding the formation of cataract.
- •9) Given consent to use device related data for scientific purpose.
- •10) No other ocular pathology or condition and pupil dilation that was
- •greater than 7.0 mm
排除标准
- •1) Concurrent participation or participation in the last 30 days in any
- •other clinical trial.
- •2) History of previous steroid - induced IOP
- •3) Patient with pigment dispersion syndrome
- •4) Taking medications that may affect vision, IOP, or ease of cataract
- •surgery (e.g., Flomax, glaucoma medications, etc.)
- •5) Acute or chronic disease or illness that would increase risk or
- •confound study results (e.g., diabetes mellitus,
- •immunocompromised, etc.).
- •6) Uncontrolled systemic or ocular disease.
- •7) Previous intra ocular or corneal surgery or history of ocular trauma. 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial
- •dystrophies).
- •9) Known pathology that may affect visual acuity; particularly retinal
- •changes that affect vision (e.g., macular degeneration, cystoid
- •macular edema, diabetic retinopathy, etc.).
- •10) Any visual disorder predicted to cause future acuity loss to a level
- •of 0.3 LogMAR or worse.
- •11) Pseudoexfoliation
- •12) Ocular hypertension ( >22 mm Hg) or glaucomatous changes in the
- •optic nerve.
- •13) Endothelial cell counts lower than 1500 cells/mm2 preoperatively
- •(based on the lowest value of three cell counts performed by
- •technician at investigative site).
- •14) Patient is pregnant, planned to become pregnant, lactating or had
- •another condition associated with the fluctuation of hormones that
- •could lead to refractive changes.
- •15) Vulnerable subject.
- •16) Black, Brunescent, traumatic or subluxated cataract.
- •17) Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris
- •atrophy, uveitis, Proliferative diabetic retinopathy at the time of
- •surgery (Random blood sugar level more than 140 mg/dl).
- •18) A history of chronic or recurrent inflammatory eye disease (e.g.
- •iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
- •19) Intraocular pressure (IOP) higher than 24 mm Hg
- •20) Surgery of the contralateral eye performed or planned within a
- •period of 7 days before or after the surgery of the studied eye
研究者
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