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临床试验/ACTRN12614000798662
ACTRN12614000798662招募中未知

The primary objective of the study is to characterize the safety(adverse events) and effectiveness (residual cylinder and visual acuity) of the ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2- SV25T5).

Alcon Laboratories (Australia) Pty Ltd0 个研究点目标入组 42 人开始时间: 2014年7月28日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
42

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
21 Years 至 o limit(—)
性别
All

入选标准

  • must sign an informed consent and be willing to come in for a visit at least 3 mths and not more than 14 mths after IOL implantation with the AcrySof IQ ReSTOR +2.5D multifocal toric IOL;must be implanted with the corrected lens based on preoperative corneal astigmatism; must complete a visit within 10 days after IOL implantation; successful capsular bag implantation with no surgical complications;

排除标准

  • IOL implanted prior to the AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric IOL; Ocular or intraocular infection or inflammation at the same time of the preoperative visit;
  • Any ocular surgery (eg. LASIK, corneal transplant, limbal relaxing incision, etc.) or intraocular laser procedure (SLT, ALT, etc.) at or prior to the surgical visit; Any conditions affecting the cornea (eg. Corneal dystrophy, severe dry eye) at the preoperative visit; Retinal conditions (e.g degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit; Known history of type 1 or 2 diabetes for more than 5 years; Any ocular or systemic co-morbidity at the preoperative visit; Pregnant at the preoperative visit or at the time of the Post-operative visit
  • ;preoperative corneal astigmatism <0.5D; participation in another clinical study at the preoperative visit or at the time of the final study visit

研究者

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