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CTRI Number  CTRI/2024/06/068460 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To Study the effect of ocular trauma on sociopsychological and economical aspect of an individual surviving the trauma 
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  SMS Medical College 
Address  Department of Ophthalmology , Charak Bhawan , S.M.S. Medical college , JLN Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9252032662  
Fax    
Email  drdschoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Dharamveer S Choudhary 
Designation  Professor  
Affiliation  SMS Medical College 
Address  Department of Ophthalmology, Charak Bhawan, JLN Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9252032662  
Fax    
Email  drdschoudhary@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Dharamveer S Choudhary 
Designation  Professor  
Affiliation  SMS Medical College 
Address  Department of Ophthalmology , Charak Bhawan , S.M.S. Medical college , JLN Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9252032662  
Fax    
Email  drdschoudhary@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical college 
 
Primary Sponsor  
Name  Department of Ophthalmology SMS Medical college Jaipur 
Address  JLN Road , 302004, Jaipur 
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  Department of Ophthalmology
Jaipur
RAJASTHAN 		 9252032662

drdschoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS COMITTEE, S.M.S. MEDICAL COLLEGE AND ATTACHED HOSPITALS , JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H545||Low vision, one eye,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with ocular injuries (only globe involving injuries) reporting to the casualty and the ophthalmology OPD and treated at department and agrees to give written consent
2. Patients of all ages who can understand the questionnaire and can reply.
 
 
ExclusionCriteria 
Details  1. Those having preexisting vision-threatening ocular diseases like glaucoma, age-related macular degeneration, etc.
2. Injury in blind or atrophic eye.
3. Comatose or unconscious patients.
4. Patients who do not agree to attend regular follow-ups or not ready to reply the questionnaire.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. 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.
2. To provide recent epidemiological data on recent trends of ocular trauma.
3. To assess the pattern of ocular trauma and visual damage.
 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To provide recent epidemiological data on recent trends of ocular trauma.
2. To assess the pattern of ocular trauma & visual damage.
 		 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/06/2024 
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="0"
Months="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drdschoudhary@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

·   Ocular injury is a significant cause of blindness worldwide that negatively affects the quality of life of the patients and their families, as well as their socioeconomic status and psychological well-being that might cause emotional problems to the trauma survivors. Patients, who experience ocular trauma can experience substantial and enduring distress and for a lengthy period after the injury itself. Aim of this study is 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. Specific history of trauma including date, time, place and nature of injury (mechanical or nonmechanical), circumstances of injury (occupational or nonoccupational), type of trauma (blunt or sharp), and mode of injury (projectile object, fall, impact), persons condition at time of injury, and information about use of protective measures at the time of injury were noted. All the information was collected in a predesigned and pretested pro forma. and a detailed interview of the enrolled patient conducted at the end of one year after trauma to know about the impact of ocular trauma on different aspect of life of the patients.

 
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