FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096620 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing an Eye Injection and Eye Drops to Control Inflammation After Cataract Surgery 
Scientific Title of Study   Posterior Subtenon Triamcinolone Acetonide and Topical Corticosteroids for Postoperative Inflammation Control Following Small Incision Cataract Surgery: A Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmi G 
Designation  Professor 
Affiliation  Sri Devaraj Urs Medical College 
Address  Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886998871  
Fax    
Email  dr.rashmi248@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yeddula Venkata Rohith Reddy 
Designation  Postgraduate Resident 
Affiliation  Sri Devaraj Urs Medical College 
Address  Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9182662619  
Fax    
Email  yeddulavenkatarohithreddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yeddula Venkata Rohith Reddy 
Designation  Postgraduate Resident 
Affiliation  Sri Devaraj Urs Medical College 
Address  Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9182662619  
Fax    
Email  yeddulavenkatarohithreddy@gmail.com  
 
Source of Monetary or Material Support  
Department of Ophthalmology,Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka 563101, India 
 
Primary Sponsor  
Name  Sri Devaraj Urs Medical College 
Address  Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka 563101, India 
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 
Rashmi G  Sri Devaraj Urs Medical College  22, Department of Ophthalmology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka 563103, India
Kolar
KARNATAKA 
9886998871

dr.rashmi248@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Research and Development Cell, SDUAHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  POSTERIOR SUBTENON TRIAMCINOLONE ACETONIDE (40 MG/ML)  Single injection of 0.5 mL (20 mg) triamcinolone acetonide administered in the posterior subtenon space at the end of small incision cataract surgery. Standard postoperative antibiotic cover given as per institutional protocol. No topical steroid drops administered postoperatively in this group. 
Comparator Agent  TOPICAL CORTICOSTEROID THERAPY (PREDNISOLONE ACETATE 1%)  Postoperative regimen of Prednisolone acetate 1% eye drops, instilled 6 times/day, tapered over 4 weeks as per standard institutional protocol. No posterior subtenon injection administered in this group. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age more than 40 years

Diagnosed with operable age-related cataract

Undergoing uncomplicated SICS with posterior chamber IOL implantation
 
 
ExclusionCriteria 
Details  Pre-existing glaucoma or ocular hypertension

History of uveitis or intraocular inflammation

Complicated cataract like traumatic, subluxated, or mature cataract with phacolytic uveitis)

Intraoperative complications like posterior capsular rupture, vitreous loss

Systemic conditions affecting ocular inflammation like uncontrolled diabetes mellitus, autoimmune disorders

Known allergy to corticosteroids

Presence of corneal opacity or dystrophy affecting examination or IOP measurement 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Degree of postoperative anterior chamber inflammation (cells and flare) on POD 1, 7, and 30  Postoperative day 1, 7, and 30 
 
Secondary Outcome  
Outcome  TimePoints 
Change in IOP from baseline

Visual acuity improvement

Incidence of adverse effects like steroid-induced IOP rise, subconjunctival hemorrhage

Patient compliance & convenience 
Postoperative day 1, 7, & 30 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 4 
Date of First Enrollment (India)   10/11/2025 
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="0"
Months="5"
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

  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 [dr.rashmi248@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2031?
    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  

This is a prospective interventional randomized parallel group active controlled clinical trial conducted in the Department of Ophthalmology RL Jalappa Hospital and Research Centre Sri Devaraj Urs Medical College Kolar. The study aims to compare the efficacy and safety of posterior subtenon triamcinolone acetonide versus topical prednisolone one percent eye drops for controlling postoperative inflammation following uncomplicated small incision cataract surgery.

A total of 66 patients aged 40 years and above with operable age related cataract will be recruited after written informed consent and randomized equally into two groups. Group A will receive a single intraoperative posterior subtenon injection of triamcinolone acetonide 40 mg per mL 0.5 mL. Group B will receive standard postoperative topical prednisolone one percent eye drops in tapering doses over four weeks.

Randomization will be done using computer generated block randomization and allocation will be concealed using sequentially numbered sealed opaque envelopes. All surgeries will be performed by a single experienced surgeon under peribulbar anesthesia. Postoperative evaluation will be conducted by a blinded observer on postoperative days 1 7 and 30. Parameters assessed include anterior chamber inflammation cells and flare intraocular pressure visual acuity and adverse events.

The primary objective is to compare the degree of postoperative anterior chamber inflammation between the two groups. Secondary objectives include assessing intraocular pressure changes visual acuity outcomes patient compliance and incidence of steroid related complications. Statistical analysis will include descriptive statistics independent t tests Chi square and Fisher exact tests and repeated measures ANOVA to evaluate outcomes over time. Sample size is 33 per group to achieve 80 percent power at 95 percent confidence to detect a clinically significant difference in postoperative inflammation.

This investigator initiated academic study aims to determine whether a single posterior subtenon injection can provide comparable or superior anti inflammatory control to standard topical steroids potentially improving patient compliance and postoperative outcomes.

 
Close