PACTR202106741373163招募中1 期
Alexandria Study I - Safety and efficacy of the complementary fixOflex-CR1 intraocular implant for cataract surgery: a prospective cohort study
EYEPCR B.V.0 个研究点目标入组 120 人开始时间: 2020年7月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •2.Cataract patients classified using LOCS III Grating, Grade 1 (Nuclear), Grade 2 (Cortical) or Grade 3 (Posterior)
- •3.Suitable to receive a standard monofocal IOL having a power range between 15 and 25 diopters
- •4.4 Clear intraocular media other than cataract
- •5.No previous intraocular or corneal surgery
- •6.No traumatic cataract
- •7.Stability of keratometry or biometry measurements. No indication of corneal ecstatic conditions or other corneal dystrophies
- •8.No irregular astigmatism
- •9.No pregnancy potential or lactation
- •10.Not concurrent participation in another drug or device investigation
- •11.Availability for postoperative follow up
- •12.Ability to sign the inform consent form
排除标准
- •1.Dense cataract
- •2.Cataract patients which also have additional anterior segment ophthalmic pathology (e.g. glaucoma, pseudoexfoliation syndrome).
- •3.Previous corneal surgeries (LASIK, PRK, CCL, etc)
- •4.Monocular patient
- •5.Patients who are not available for post operative follow up
- •6.6. Patients who cannot consent to their enrolment the study.
研究者
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