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临床试验/CTRI/2022/08/045110
CTRI/2022/08/045110招募中4 期

A Proof-of-Concept, Prospective, Open label, Randomized Controlled Clinical Study Evaluating RevitalVision® Therapy for Improving Uncorrected Visual Acuity (UCVA) and Contrast Sensitivity Function (CSF) in Cataract Patients Following Diffractive IOL Implantat.

one0 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
one

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.Subject, man & woman 50 to 80 years old, post cataract surgery with Diffractive IOL implants 12 to 52 weeks following surgery.
  • 2.Subject with BCVA better than 6 of 9 at least in one eye.
  • 3.Subject with UCVA 6by6 â?? 6 of 15 at least in one eye.
  • 4.Subject with Contrast Sensitivity Function below-normal range, measured in FACT sine wave test chart during screening visit.
  • 5.Subject complaining on vision quality.
  • 6.Subject is able to sign on informed consent.
  • 7.Subject is willing and declare his/her motivation to practice 3 to 4 times per week x 30 minutes each training, for 8 consecutive weeks.
  • 8.Subject who is able to participate in complete ophthalmic and ocular evaluation based on the study PI decision.
  • 9.Subject has a Personal Computer with window OS or MAC IOs (Operating System) with screen size 15-26 inch at home and with internet connection.
  • 10.Subject pass successfully Computerized Evaluation 1 and 2 as defined by RV system.

排除标准

  • 1.Subject who has unstable vision based on PI decision
  • 2.Subject with severe untreated attention disorder.
  • 3.Subject who suffer from chronic migraines based on subject self-reporting
  • 4.Subject who diagnosed with Epilepsy
  • 5.Subject who has any ocular disease beside cataract.
  • 6.Subject who has any behavioral or neurological disorders which may interfere with the study, based on PI discursion
  • 7.Subject who has any physical or mental impairment precluding study compliance, based on PI discursion
  • 8.Unstable health condition, which may prevent from completing the study and follow up visits. Based on PI decision.
  • 9.Treated with medication that may affect vision quality.

研究者

发起方
one

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