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CTRI Number  CTRI/2024/12/078797 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 22/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Eye injury-its effect on social, economical, psychological aspect among patients having eye injuries in terms of poor to nil vision . 
Scientific Title of Study   To study the outcomes of ocular trauma in terms of visual disability and its effect on the social , economic, and psychological aspect among patients surviving with the traumatic eye. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharamveer S Choudhary 
Designation  Professor 
Affiliation  Swai man singh medical college jaipur 
Address  Department of Ophthalmology, S.M.S Medical college JLN Road , Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9252032662  
Fax    
Email  drdschoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raman  
Designation  Resident  
Affiliation  Swai man singh medical college jaipur 
Address  Department of Ophthalmology, S.M.S Medical college JLN Road , Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  7727888469  
Fax    
Email  beniwalraman@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dharamveer S Choudhary 
Designation  Professor 
Affiliation  Swai man singh medical college jaipur 
Address  Department of Ophthalmology, S.M.S Medical college JLN Road , Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9252032662  
Fax    
Email  drdschoudhary@gmail.com  
 
Source of Monetary or Material Support  
Department of ophthalmology Charak bhawan S.M.S Medical college and hospital Jawahar lal Nehru marg Jaipur Rajasthan India 302004 
 
Primary Sponsor  
Name  SMS medical college Jaipur  
Address  department of ophthalmology , S.M.S Medical college ,JLN Road Jaipur 302004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharamveer S Choudhary  S.M.S medical college jaipur  Department of ophthalmology Charak bhawan S.M.S medical college and hospital , JLN Road , Jaipur 302004
Jaipur
RAJASTHAN 		 9252032662

drdschoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethics Comittee S.M.S Medical college and Attached Hospital Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H55-H57||Other disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with ocular injuries reporting to the casualty and the ophthalmology OPD agree to give written consent 
 
ExclusionCriteria 
Details  Those having preexisting vision threatening ocular diseases like glaucoma, age-related macular degeneration , etc.
Injury in blind or atrophic eye
Comatose or unconscious patients.
Patients who were not agree to attend regular follow ups .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
visual outcomes   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
social , economical , psychological impact   12 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   30/01/2025 
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="0"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  can be shared as per law

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available with authorities at SMS Medical college Jaipur as per law

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 31-08-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   As per the world health Organization (WHO) Blindness Data Bank approximately 55 million eye injuries occur worldwide annually , resulting in about 23 million individuals with at least unilaterally poor vision.
In India , over 50 million people suffer from blindness among them , 1.2% cases of blindness are caused by avoidable ocular injuries .
Ocular injury is a significant cause of blindness worldwide that negatively affects the quality of life the patients and their families , as well as their socioeconomic status and psychological well-being.
 
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