CTRI/2023/03/050394招募中4 期
A prospective, open-label clinical study to evaluate performance and safety of the Phacoemulsification Machine with Accessories.
Grewal Eye Institute0 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
- 招募中
- 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.Cataracts for which cataract extraction
- •and posterior chamber IOL implantation
- •have been planned & possible
- •2.Availability, willingness, ability and
- •sufficient cognitive awareness to comply
- •with study requirements, examination
- •procedures and visits
- •4.Be willing to provide informed consent and
- •authorization to disclose protected health
- •information or equivalent documentation
- •necessary to comply with applicable
- •privacy laws pertaining to medical
- •procedures in the governing countries
- •5.A transparent central cornea
- •6.A preoperative central endothelial cell
- •count of =1500 cells per square millimeter
- •7.Patients willing to attend all follow-up
- •appointments
- •8.Patients must sign and be given a copy of
- •the written Informed Consent form
排除标准
- •1. Preoperative ocular pathology that can affect visual acuity
- •2. Corneal irregularities such as keratoconus, corneal dystrophy,
- •corneal opacities
- •3. Previous intraocular or corneal surgery
- •4. Other ocular surgery at the time of the cataract extraction
- •5. Subject with acute and chronic disease or illness that would
- •increase the operative risk or confound the outcomes of the
- •6. Subject with primary open angle or narrow angle glaucoma
- •7. Patient with cardiac pacemaker
- •8. Previous or pre-existing ocular disease that would preclude post operative visual acuity of 20/60 or better subject with
- •Keratoconus, pellucid Marginal degeration & other corneal
- •ectasia disease.
- •9. Subject having ocular hypertension in either eye
- •10. Subject taking systematic medication that can confound the
- •outcome of the study or increase the risk to the subject
研究者
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