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CTRI Number  CTRI/2024/09/074457 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To compare CRP albumin ratio, neutrophil lymphocyte ratio and platelet lymphocyte ratio between normal and non-infectious uveitis patients which help us in prognostication and treatment of the disease. 
Scientific Title of Study   Assessing implications for prognosis and management of non-infectious uveitis based on novel inflammatory serum biomarkers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minija Ck 
Designation  Senior consultant, Medical Retina and Uvea services, Sankara Eye Hospital, Bangalore 
Affiliation  Sankara eye hospital 
Address  Room number 26, Department of Medical Retina and uvea services,Sankara eye hospital, varthur main road, kundalahalli gate

Bangalore
KARNATAKA
560037
India 
Phone  9480587018  
Fax    
Email  minija_ck@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neethu Narasimhaiah 
Designation  Fellow, Medical Retina and Uvea 
Affiliation  Sankara eye hospital 
Address  Room number 26, Department of Medical Retina and Uvea services, Sankara eye hospital varthur main road kundalahalli gate

Bangalore
KARNATAKA
560037
India 
Phone  7022943710  
Fax    
Email  neet.capricorn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neethu Narasimhaiah 
Designation  Fellow, Medical Retina and Uvea 
Affiliation  Sankara eye hospital 
Address  Room number 26, Department of Medical Retina and Uvea services,Sankara eye hospital varthur main road kundalahalli gate

Bangalore
KARNATAKA
560037
India 
Phone  7022943710  
Fax    
Email  neet.capricorn@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Varthur main road, kundalahalli gate, Bengaluru 560037 
 
Primary Sponsor  
Name  Sankara eye hospital 
Address  Sankara eye hospital varthur main road kundalahalli gate bengaluru 560037 
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 Neethu Narasimhaiah  Sankara Eye Hospital  Room number 26, Department of Medical Retina and Uvea services,Sankara Eye Hospital, varthur main road, kundalahalli gate, Bangalore 560037
Bangalore
KARNATAKA 		 7022943710

neet.capricorn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sankara Eye Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H22||Disorders of iris and ciliary bodyin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients presenting with first attack of active uveitis (anterior, intermediate, posterior and panuveitis) 
 
ExclusionCriteria 
Details  Patients with infectious uveitis.
Intraocular surgery in the last 3 months.
Having a history of ocular trauma or chronic medication use.
Acute or chronic systemic infective disorders, cancer.
Acute coronary syndrome, cerebral disease, trauma or anemia.
Those using anti-inflammatory or immunosuppressive drugs.
Pregnant women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the levels of CRP, CRP - albumin ratio(CAR), neutrophil to lymphocyte ratio (NLR), platelet to
lymphocyte ratio (PLR) and systemic immune-inflammation index (SII) in patients with active non-
infectious uveitis and comparison with normal controls.
 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To study the correlation between different novel biomarkers and its significance.  At baseline 
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
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)   10/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Uveitis causes serious complications; e.g., chronic eye inflammation, keratopathy, cataract, glaucoma, macular edema, retinal detachment, and result in permanent vision loss if not diagnosed and treated promptly.
To identify if C-reactive protein (CRP)/albumin ratio (CAR) and systemic immune-inflammation index (SII) in patients with non-infectious uveitis during an attack is a marker that can give information about the activity, severity and prognosis of the disease. No prospective study is done in the past. No Indian study in the past. Identification of patients with noninfectious uveitis requiring steroid-sparing immunomodulatory therapy (IMT) is currently lacking in objective molecular biomarkers. Early detection of this can help prevent recurrence and complications of disease.
 
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