A computerized visual training study for visual stimulation in Patients Suffering from Keratoconus.

Phase 4

• Conditions: Health Condition 1: H530- Amblyopia ex anopsia

• Registration Number: CTRI/2022/09/045779
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients improving distance Best Corrected Distance Visual Acuity by at least 2 line at study end in comparison to baseline.Timepoint: Screening, Treatment -Baseline, Week 1-3, Week 6, Week 12 & Follow up - Week 26 & Week 50

Secondary Outcome Measures

Name	Time	Method
1.Percentage of patients improving Contrast Sensitivity Function by at least 50% in Functional Acuity Contrast Test sine wave (FACT) at study end (12-14 weeks) in comparison to baseline. <br/ ><br>2.Percentage of patients improving Best Corrected Near Visual Acuity by at least 2 line at study end (18-20 weeks) in comparison to baseline. <br/ ><br>3.Percentage of patients improving distance Best Corrected Visual Acuity Distance & Near, by at least 2 line in comparison to baseline (26 weeks, follow up). <br/ ><br>4.Percentage of patients improving Contrast Sensitivity Function by at least 50% in Functional Acuity Contrast Test sine wave (FACT), in comparison to baseline ( 46-50 weeks, follow up)Timepoint: 12-14 weeks; 18-20 weeks; 26 weeks & 46-50 weeks