| 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
|
|
|
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
|
|
|
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. |