FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/092107 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Eye Assessment for Keratoconus and Vision in children 
Scientific Title of Study   Pediatric Eye Assessment for Keratoconus and Vision (PEAK-VISION) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRashmi Deshmukh 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  Room No: 124, GPR international centre for advancement of rural eye care(ICARE), kismatpur road, Abhyudaya nagar, Dargh Khaleej Khan, Himayat sagar, Hyderabad

Hyderabad
TELANGANA
500030
India 
Phone  8098815887  
Fax    
Email  rashmi.deshmukh@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  DrRashmi Deshmukh 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  Room No: 124, GPR international centre for advancement of rural eye care(ICARE), kismatpur road, Abhyudaya nagar, Dargh Khaleej Khan, Himayat sagar, Hyderabad

Hyderabad
TELANGANA
500030
India 
Phone  8098815887  
Fax    
Email  rashmi.deshmukh@lvpei.org  
 
Details of Contact Person
Public Query  
Name  DrRashmi Deshmukh 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  Room No: 124, GPR international centre for advancement of rural eye care(ICARE), kismatpur road, Abhyudaya nagar, Dargh Khaleej Khan, Himayat sagar, Hyderabad

Hyderabad
TELANGANA
500030
India 
Phone  8098815887  
Fax    
Email  rashmi.deshmukh@lvpei.org  
 
Source of Monetary or Material Support  
1. LV Prasad Eye Institute,Room No: 124,GPR international centre for advancement of rural eye care,kismatpur road,Hyderabad 500030. 2.LV Prasad Eye Institute,Mithu Tulsi Chanrai campus Refractive clinic,Ground floor,Patia,Bhubaneswar 751024,Odisha.3.L V Prasad Eye Institute,Kode venkatadri chowdary campus,Refractive clinic, ground floor,Tadigadapa, Vijayawada,Andhrapradesh 
 
Primary Sponsor  
Name  Infosys Foundation 
Address  Neralu, #1/2 (1878), 11 th main, 39 cross, 4th T Block, Jaynagar, Bangalore, 560011 
Type of Sponsor  Other [Non Profitable Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRashmi Deshmukh  L V Prasad Eye Institute  Mithu Tulsi Chanrai campus Refractive clinic,Ground floor,Patia,Bhubaneswar 751024,Odisha.
Khordha
ORISSA 		 8098815887

rashmi.deshmukh@lvpei.org 
DrRashmi Deshmukh  L V Prasad Eye Institute  Room No: 124,GPR international centre for advancement of rural eye care,kismatpur road,Hyderabad 500030.
Hyderabad
TELANGANA 		 8098815887

rashmi.deshmukh@lvpei.org 
DrRashmi Deshmukh  L V Prasad Eye Institute  Kode venkatadri chowdary campus,Refractive clinic, ground floor,Tadigadapa, Vijayawada,Andhrapradesh
Krishna
ANDHRA PRADESH 		 8098815887

rashmi.deshmukh@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
L V Prasad Eye Institute, Ethics Committee  Approved 
L V Prasad Eye Institute, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Keratoconus and anterior segment disorders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  All children enrolled in schools aged 5-16 years will be included in the study 
 
ExclusionCriteria 
Details  Children whose parents do not provide consent to participate in the study will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Number of schools covered during the project duration
2.Number of children screened
3.Number of children provided free eyeglasses
4.Number of children provided low vision assessment and management
5.Number of children referred to and attended referral services for other eye conditions and keratoconus
6.Number of children received medical and surgical services

 		 Only screening visit 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="200000"
Sample Size from India="200000" 
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)   11/08/2025 
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="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Trained field workers will collect demographic details and perform initial vision screening using 6/12 Tumbling E Snellen optotype kept at 3 meters distance to identify children with VI. Following which a torch light examination will be carried out to identify any obvious eye abnormalities. Children who fail the vision screening (minimum of 3 out of 5 letters is considered as pass) and/or found to have any ocular abnormalities in the torch light examination will be referred to a nearby Vision centre (VC), secondary (SC) or tertiary care centre (TC). All children who fail the vision screening will also undergo dry refraction using Heine Beta Retinoscope and slit lamp examination using Hand-held Keeler PSL classic Slit lamp by an optometrist/Vision technician (VT) within the school premises and will be provided with eye glasses free of charge. Children who are 10 years and older will undergo corneal topography (non-invasive) using a Pentacam or a portable Remidio corneal topographer by an optometrist/VT within the school premises on the same day or on another day.

 
Close