| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.rashmi248@gmail.com].
- 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.
- 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. |