CTRI/2023/03/050364尚未招募4 期
Prospective, randomized, comparative clinical investigation to evaluate and compare the performance & safety of two different OVDs in patient undergoing cataract surgery.
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
- •Inclusion Criteria:
- •1) Unilateral/Bilateral
- •2) Age18yearorgreater
- •3) Cataractforwhichphacoemulsificationextractionandposterior
- •chamber IOL implantation was planned in at least one eye of the
- •4) Clearintraocularmediaotherthancataract
- •5) Signedinformedconsent
- •6) Patient who are willing to attend all the regular follow-up
- •examinations as per the study schedule.
排除标准
- •1) Concurrent participation or participation in the last 30 days in any other clinical trial.
- •2) Historyofprevioussteroid-inducedIOP
- •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) Uncontrolledsystemicoroculardisease.
- •7) Historyofoculartraumaorpriorocularsurgery
- •8) Corneal abnormalities (e.g., stromal, epithelial or endothelial
- •dystrophies)
- •9) Knownpathologythatmayaffectvisualacuity;particularlyretinal
- •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.
研究者
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