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CTRI Number  CTRI/2024/09/073354 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   OCT ANGIOGRAPHY IN EYE INFLAMMATION 
Scientific Title of Study   OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN ANTERIOR AND POSTERIOR UVEITIS - A PROSPECTIVE STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhijeet jha  
Designation  DNB Resident 
Affiliation  DIPLOMAT OF NATIONAL BOARD (NBEMS) 
Address  C/o Sr ranganath 334 1st A Main Road 7th Block Jayanagar West BANGALORE
Jayanagar West BANGALORE
Bangalore
KARNATAKA
560070
India 
Phone  9617646588  
Fax    
Email  abhijeetjha.jha1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep TM  
Designation  Consultant vitreo retina  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  #299, 15 the cross, 7th main HSR layout 6th sector BANGALORE
256/14 , KANAKPURA ROAD , 7TH BLOCK, JAYANAGAR , BENGALURU KARNATAKA 560070
Bangalore
KARNATAKA
560102
India 
Phone  9738501058  
Fax    
Email  pradeep161989@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pradeep TM 
Designation  Consultant vitreo retina  
Affiliation  Nethradhama Super Speciality Eye Hospital 
Address  #299, 15th cross, 7th main HSR layout 6th sector BANGALORE
256/14, KANAKAPURA ROAD, 7TH BLOCK , JAYANAGAR , BENGALURU KARNATAKA 560070
Bangalore
KARNATAKA
560102
India 
Phone  973801058  
Fax    
Email  pradeep161989@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama Super Speciality Eye Hospital Jayanagar Bangalore  
 
Primary Sponsor  
Name  Nethradhama Super Speciality Eye Hospital Jayanagar  
Address  #256/14,Kanakapura Main Road 7th Block Jayanagar Bangalore Karnataka  
Type of Sponsor  Research institution and hospital 
 
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 Pradeep Tm  Nethradhama Super Speciality Eye Hospital   #256/14, Kanakapura Main Road 7th Block Jayanagar BANGALORE
Bangalore
KARNATAKA 		 9738501058

pradeep161989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for research on human subjects   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Voluntarily willing to participate in study
Chronic posterior uveitis
Acute active anterior and posterior uveitis
STABLE FIXATION  
 
ExclusionCriteria 
Details  Diabetic retinopathy
INFLAMMATION SECONDARY TO TRAUMA AND SURGERY
Macular bleed
Prior Retinal detachment  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Foveal avascular zone superficial and deep comparison in PATIENTS WITH anterior and PATIENTS WITH posterior uveitis   COMPARISON IS DONE IN SINGLE VISIT 1 WEEK AFTER INITIAL PRESENTATION 
 
Secondary Outcome  
Outcome  TimePoints 
Establishment of OCTA in
Diagnosis of anterior and posterior uveitis  		 18 months  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 31-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Optical coherence tomography angiography in anterior and posterior uveitis
We are using OCTA which is an alternative to conventional eye angiography FFA. FFA uses dye for study which has many side effects and we can’t do it in CKD patients 
So OCTA is going to help in future for such patients 
 
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