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CTRI Number  CTRI/2024/09/073833 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Effects of Intraoperative Intravitreal Triamcinolone Acetonide on Visual Outcomes and Postoperative Recovery in Uveitic Cataract Patients Undergoing SICS 
Scientific Title of Study   A study on the impact of intraoperative Intravitreal Triamcinolone Acetonide injection on visual outcome, postoperative complications and visual rehabilitation in patients of uveitic cataract undergoing SICS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MIRZA MARIYAM BEG 
Designation  Junior Resident 
Affiliation  Moti Lal Nehru Medical college 
Address  Ophthalmology Department, Regional Institute of Ophthalmology.

Allahabad
UTTAR PRADESH
211001
India 
Phone  7985032898  
Fax    
Email  dr.mirzamariyam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SANTOSH KUMAR 
Designation  Professor 
Affiliation  MOTI LAL NEHRU MEDICAL COLLEGE 
Address  Ophthalmology Department, Regional Institute of Ophthalmology.

Allahabad
UTTAR PRADESH
211001
India 
Phone  9412247373  
Fax    
Email  drsantosh7373@gmail.com  
 
Details of Contact Person
Public Query  
Name  SANTOSH KUMAR 
Designation  Professor 
Affiliation  MOTI LAL NEHRU MEDICAL COLLEGE 
Address  Ophthalmology Department, Regional Institute of Ophthalmology.

Allahabad
UTTAR PRADESH
211001
India 
Phone  9412247373  
Fax    
Email  drsantosh7373@gmail.com  
 
Source of Monetary or Material Support  
Moti Lal Nehru Medical College, George Town, Allahabad. Pincode-211001 
 
Primary Sponsor  
Name  Moti Lal Nehru Medical College  
Address  George Town, Allahabad. Pincode-211001 
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 Mirza Mariyam Beg  Moti Lal Nehru Medical College  Department of Ophthalmology ,George Town, Allahabad. Pincode -211001
Allahabad
UTTAR PRADESH 		 7985032898

dr.mirzamariyam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MLN MEDICAL COLLEGE AND ASSOCIATE HOSPITALS, PRAYAGRAJ  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  Intravitreal Triamcinolone Acetonide injection  3 mg/ml (0.075ML)Triamcinolone Acetonide Intravitreal injection is given intraoperatively once and the patient is followed up for 1 year. 
Comparator Agent  no drug given  no drug is given to the control group. Patient only undergoes small incision cataract surgery 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1.Diagnosis of uveitis consistent with Standardization Uveitis Nomenclature (SUN).
2.Intraocular inflammation had been controlled without using topical or oral corticosteroid for atleast 3 months before surgery . 
 
ExclusionCriteria 
Details  Exclusion Criteria :
1.Infectious uveitis.
2. Previous intraocular surgery .
3.Patients with history of glaucoma or high myopia, optic neuropathy, media opacity other than cataract .
4.Patients less than 18 years or with juvenile rheumatoid arthritis.
5.Retinal or choroidal disease.
6.Intraoperative posterior capsular rupture or viterous loss. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 visual acuity
2 Intraocular pressure
3 central Macular Thickness
4 Anterior Chamber reaction
5 endothelial cell density
 		 postoperative day 1
1 week
1 month
2 months
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative complications  postoperative day 1
1 week
1 month
2 months
3 months
6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 30-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 it is a randomized prospective interventional study. it will be conducted at a tertiary eye care center over a year with a sample size of 30 patients. The study aims to compare the outcome of uveitic cataract patients undergoing small incision cataract surgery with and without a 3mg intravitreal triamcinolone acetonide injection, focusing on visual outcomes, complications, and rehabilitation.   
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