CTRI/2019/12/022318尚未招募4 期
A prospective, comparative, randomized clinical study to compare and evaluate the safety, efficacy and refractive outcome of three different Hydrophilic Monofocal Intraocular Lens implanted to cataract patients. - BTVCPL-HFIOL-2019-02
Biotech Vision Care 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 Cataract
- •2.Patients with age > 50 years.
- •3.Patients with Grade I or Grade II cataract as per Lens Opacities Classification System III (LOCS-III).
- •4.Patients that have healthy eyes excluding the formation of senile cataract.
- •5.Patient who are ready to attended all the regular follow-up examinations as per the routine schedule.
排除标准
- •1.Patients receiving Chloroquine treatment.
- •2.Preoperative corneal astigmatism > 1.
- •3.Baseline endothelial cell density < 1500 cells/mm2 in the operative eye.
- •4.Amblyopia, Microphthalmia, Glaucoma, Pseudoexfoliation Syndrome with Glaucoma, Iris atrophy, Proliferative diabetic retinopathy and all retinal pathologies.
- •5.A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
- •6.Previous intra-ocular or corneal surgery.
- •7.Pregnant or lactating mother.
- •8.Concurrent participation in another drug or device Study
研究者
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