A Proof-of-Concept, Prospective, Open label, Randomized Controlled Clinical Study Evaluating RevitalVisionÂ® Therapy for Improving Best Corrected Visual Acuity (BCVA) and Contrast Sensitivity Function (CSF) in Patients Suffering from Keratoconus.

one0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

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•1. Subject, man & woman 14-55 years old, who is diagnosed with stable keratoconus,
•2. Subject with stable BCVA for 12 months prior to baseline - based on the study PI decision.
•3. Stable keratoconus parameters including Kmax, Ksteep, astigmatism and corneal thickness in the past 12 months.
•4. Subject is able to sign on informed consent.
•5. Subject is willing and declare his/her motivation to practice 3-4 times per week x 30 minutes each training, for 12 consecutive weeks.
•6. Subject who is able to participate in complete ophthalmic and ocular evaluation based on the study PI decision.
•7. Subject with Best Spectacle Corrected monocular Visual Acuity measured in the range between 6 of 9 to 6 of 30 inclusive, using ETDRS VA test chart prior or during the screening visit.
•8. Subject with Contrast Sensitivity Function below-normal range, measured in FACT sine wave test chart during screening visit.
•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.

•1. Subject who has unstable vision in the last 12 months based on PI decision.
•2. Subject after crosslinking surgery performed in the past 12 months
•3. Subject with diabetes.
•4. Subject with sever untreated attention disorder.
•5. Subject who suffer from chronic migraines based on subject self-reporting.
•6. Subject who diagnosed with Epilepsy.
•7. Subject who has any ocular disease beside keratoconus.
•8. Subject who has any behavioral or neurological disorders which may interfere with the study, based on PI discursion.
•9. Subject who has any physical or mental impairment precluding study compliance, based on PI discursion
•10. Unstable health condition, which may prevent from completing the study and follow up visits. Based on PI decision.

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