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CTRI Number  CTRI/2025/11/096860 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study Comparing Eye Injection and Eye Drops for Recovery After Cataract Surgery in Diabetic and Non-Diabetic Patients 
Scientific Title of Study   Comparative Evaluation of Inflammatory and Visual Outcomes in Diabetic and Non-Diabetic Patients Undergoing Cataract Surgery: Intraoperative Subconjunctival Steroid Depot versus Conventional Topical Therapy 
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 Yuvarani 
Designation  Research Coordinator  
Affiliation  Aravind Eye Hospital  
Address  Room No: 111, Department of cataract and IOL Services, Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8939967945  
Fax    
Email  yuvaranidevaraj16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yuvarani 
Designation  Research Coordinator  
Affiliation  Aravind Eye Hospital  
Address  Room No: 111, Department of cataract and IOL Services, Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8939967945  
Fax    
Email  yuvaranidevaraj16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yuvarani 
Designation  Research Coordinator  
Affiliation  Aravind Eye Hospital  
Address  Room No: 111, Department of cataract and IOL Services, Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8939967945  
Fax    
Email  yuvaranidevaraj16@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai 600077, Tamil Nadu, India  
 
Primary Sponsor  
Name  Aravind Eye Hospital  
Address  Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai 600077, Tamil Nadu, India  
Type of Sponsor  Private hospital/clinic 
 
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 Yuvarani   Aravind Eye Hospital   Room Number: 111, Department of Cataract and IOL Services, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU 
8939967945

yuvaranidevaraj16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Chennai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H25||Age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age 40 years to 99 years
Patients undergoing uncomplicated phacoemulsification with IOL Implantation
Group 1: Known Type 2 Diabetes patients without Diabetic retinopathy, or with mild diabetic retinopathy
Group 2: Non-diabetic patients
 
 
ExclusionCriteria 
Details  History of uveitis, glaucoma, or ocular hypertension
Intraoperative complications
Combined ocular surgeries
Use of systemic steroids or immunosuppressants
Allergy to corticosteroids or study medications
Moderate, Severe NPDR or PDR, macular edema
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the anterior chamber inflammation in diabetic and non-diabetic patients undergoing cataract surgery in both regimens
 
Postoperative Day 1, Day 21, and Month 3 
 
Secondary Outcome  
Outcome  TimePoints 
To compare visual acuity outcomes at postoperative day (POD) 1, day 21, and day 90 in both regimens
To assess changes in intraocular pressure (IOP) following cataract surgery in both regimens
To evaluate and compare the incidence of postoperative cystoid macular edema
 
Postoperative Day 1, Day 21, and Month 3 
 
Target Sample Size   Total Sample Size="768"
Sample Size from India="768" 
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)   11/11/2025 
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="1"
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  

This study aims to compare two methods of controlling postoperative inflammation following cataract surgery in diabetic and non-diabetic patients. Effective management of inflammation is crucial for optimal visual recovery, especially in diabetic patients who are at higher risk of exaggerated inflammatory responses and complications such as cystoid macular edema.

Patients undergoing cataract surgery in this observational study will receive treatment according to standard clinical practice. One group receives a single intraoperative subconjunctival steroid depot injection, while the other receives conventional postoperative eye drops (steroid and NSAIDs). Both groups receive standard antibiotic eye drops to prevent infection.

The primary outcomes include control of anterior chamber inflammation (measured by cells and flare grading) and visual acuity recovery. Secondary outcomes include intraocular pressure changes, incidence of postoperative cystoid macular edema, etc. Assessments will be conducted on postoperative Day 1, Day 21, and Day 90.

Patients receiving the subconjunctival depot are expected to have non-inferior control of inflammation and visual outcomes compared to conventional topical therapy. This study will provide evidence on whether a single depot injection can be as effective as multiple daily eye drops, potentially reducing patient burden and improving compliance, particularly in diabetic patients with higher postoperative risk.

By comparing outcomes in both diabetic and non-diabetic patients, this study will help guide clinical decision-making and optimize postoperative care in routine cataract surgery.

 
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