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CTRI Number  CTRI/2022/05/042734 [Registered on: 23/05/2022] Trial Registered Prospectively
Last Modified On: 12/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Computerised vision therapy]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the improvement in vision and Contrast sensitivity using a computer based software Revital Vision therapy in patients with Corneal thinning (Keratoconus) after Collagen cross linking procedure ,after Post laser power correction and after cataract surgery with multifocal IOLs  
Scientific Title of Study   "A stratified randomized clinical study evaluating RevitalVision therapy for improving best- corrected visual acuity and contrast sensitivity function in patients a) with stable keratoconus and those who have undergone Collagen Cross-linking surgery b) who have undergone laser Refractive surgery and c) who have undergone phaco-emulsification with extended depth of focus or multifocal IOLs" 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prema padmanabhan 
Designation  Distinguished Senior consultant and Medical Director 
Affiliation  Ophthalmologist, Sankara Nethralaya 
Address  Sankara Nethralaya, Medical and Vision Research Foundation,
18 College Road, Nugambakkam, Chennai- 600 006 Tamilnadu India
Chennai
TAMIL NADU
600006
India 
Phone  42271500  
Fax    
Email  drpp@snmail.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachapalle Reddi Sudhir 
Designation  Senior cornea consultant 
Affiliation  Ophthalmologist, Sankara Nethralaya 
Address  Sankara Nethralaya, Medical and Vision Research Foundation,
18 College Road, Nugambakkam, Chennai- 600 006 Tamilnadu India
Chennai
TAMIL NADU
600006
India 
Phone  42271500  
Fax    
Email  drrrs@snmail.org  
 
Details of Contact Person
Public Query  
Name  Dr Rachapalle Reddi Sudhir 
Designation  Senior cornea consultant 
Affiliation  Ophthalmologist, Sankara Nethralaya 
Address  Sankara Nethralaya, Medical and Vision Research Foundation,
18 College Road, Nugambakkam, Chennai- 600 006 Tamilnadu India
Chennai
TAMIL NADU
600006
India 
Phone  42271500  
Fax    
Email  drrrs@snmail.org  
 
Source of Monetary or Material Support  
Medical Research Foundation Sankara Nethralya  
 
Primary Sponsor  
Name  Medical Research Foundation Sankara Nethralya  
Address  Sankara Nethralaya Medical Research Foundation 18 college road Nungambakkam Chennai 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Revital Vision   Hamaayan street 2 Modiin 7177871 Israel 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachapalle Reddi Sudhir  Medical Research Foundation Sankara Nethralaya  Department of Cornea and Refractive services, Sankara Nethralaya, Medical and Vision Research Foundation, 18 College Road, Nugambakkam, Chennai- 600 006
Chennai
TAMIL NADU 		 044-28156172

drrrs@snmail.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H537||Vision sensitivity deficiencies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Revital Vision Placebo Software  Revital Vision Placebo Software using Gabor patch without customization , computerized vision therapy for a period of 12 weeks and followed upto 1 year 
Intervention  RevitalVision’s perceptual learning therapy  Computerised vision therapy Using Gabor Patch and customization as per patients need for a duration of 12 weeks of vision therapy and followed upto 1 year 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Post Lasik Surgery(Cohort 1)
Age for Post Refractive surgery 18-35 years
Recruitment after 1 month of after Refractive surgery (LASIK/ EPI LASIK)
All subjects with best-corrected visual acuity of 6/12 or better
Subjects with subnormal contrast sensitivity
Minimum requirement- laptop with a 15-inch screen with mouse and an internet connection at home
Post Collagen Cross-Linking(Cohort 2)
Age for Post Collagen Cross-Linking Surgery 10 years onwards
Recruitment: Patients with stable keratoconus for over 12 months, and patients after 3 months of Collagen Cross-Linking surgery
All subjects with best-corrected visual acuity of 6/12 or better
Subjects with subnormal contrast sensitivity
Minimum requirement- laptop with a 15-inch screen with mouse and an internet connection at home.

Post Cataract Surgery EDOF or multifocal IOLs(Cohort 3)
Age for Post Cataract surgery 40-75 yrs
Recruitment 4 weeks after multifocal IOL implantation.
All subjects with best-corrected visual acuity of 6/12 or better
Subjects with subnormal contrast sensitivity
Minimum requirement- laptop with a 15-inch screen with mouse and an internet connection at home
 
 
ExclusionCriteria 
Details  Post Lasik Surgery(Cohort 1)
Presence of ocular co morbidities
Subject with severe untreated attention disorder
Subject who suffers from chronic migraine
Epilepsy
Post Collagen Cross-Linking(Cohort 2)
Presence of ocular co morbidities
Subject with severe untreated attention disorder
Subject who suffers from chronic migraine
Epilepsy
Post Cataract Surgery EDOF or multifocal IOLs (Cohort 3)
Presence of ocular co morbidities
Subject with severe untreated attention disorder
Subject who suffers from chronic migraine
Epilepsy 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome measure: Improvement in Best Corrected Visual Acuity and Contrast Sensitivity Function.
Change in Best Corrected Visual Acuity and Contrast Sensitivity Function in patients after Refractive surgery, Collagen cross linking and Phacoemulsification with extended depth of focus or multifocal IOLs 		 Evaluated at 12 weeks , 6 months and at the end of one year 
 
Secondary Outcome  
Outcome  TimePoints 
To improve self-reported Quality of Vision, and overall binocular vision.   12 weeks 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background:

A Study by Durrie D et al showed that the NeuroVision technology is effective in improving UCVA and unaided CSF in low myopia and early presbyopia1. Another study showed the induced longer-range facilitation is a result of internal response transmission. This results in cascade of neural reactions which induce plasticity in the cortex. The existence of neural plasticity in an adult brain is proven, i.e., Visual improvement in adults can be achieved by perceptual learning3. It was shown that significant neural activity can be achieved by applying "lateral masking technique" using Gabor Patches. But there seems to be no data on the stability of the improved visual acuity and contrast sensitivity for a longer duration. Also clinical trials have not yet been done on subjects after collagen cross linking.

Aims and objectives:

To assess the efficacy of Gabor patch based treatment in improving best corrected visual acuity and contrast sensitivity function in patients after collagen cross linking, refractive surgery and phacoemulsification with extended depth of focus or multifocal IOLs.
To evaluate percentage of patients improving distance and near BCVA by at least 1 line at study end (8-12 weeks) and after one year (follow up) in comparison to baseline
Percentage of patients improving CSF by at least 50% in VectorVision CSV-1000  at study end (8-12weeks) and after one year (follow up) in comparison to baseline.                         
Percentage of patients improving Non-Strabismic Binocular Vision Anomalies at the study end (8-12 weeks) and after one year (follow up) in comparison to baseline
Percentage of patients improving self-reported QoV questionnaire at study end (8-12 weeks) and after one year (follow up) in comparison to baseline.

Expected results:

In treatment group, we expect an improvement in distance and near BCVA by at least 4 line, CSF by at least 50%, self-reported Quality of vision questionnaire by the end of 34weeks. In Placebo group, we expect no improvement

Reference:

1.    Durrie, D., & McMinn, P. S. (2007). Computer-based primary visual cortex training for treatment of low myopia and early presbyopia. Transactions of the American Ophthalmological Society, 105, 132.

2.    Polat, U., & Sagi, D. (1994). Spatial interactions in human vision: from near to far via experience-dependent cascades of connections. Proceedings of the National Academy of Sciences, 91(4), 1206-1209. 

3.    Polat U., Mizobe, K., Kasamatsu, T., Norcia A.M. (1998). Collinear stimuli regulate visual responses depending on Cell’s contrast threshold. Nature, 391, 580-584. 

 
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