| CTRI Number |
CTRI/2025/08/093238 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of perioperative subconjunctival triamcinolone acetonide injection versus postoperative topical prednisolone following phacoemulsification for prevention of intra-ocular inflammation. |
|
Scientific Title of Study
|
Comparative evaluation of perioperative subconjunctival triamcinolone acetonide injection versus postoperative topical prednisolone for prevention of intra-ocular inflammation following phacoemulsification |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Singh |
| Designation |
Junior Resident |
| Affiliation |
school of medical sciences and research |
| Address |
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
07388270452 |
| Fax |
|
| Email |
2023000936.ankita@pg.sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abha Gahlot |
| Designation |
Professor |
| Affiliation |
school of medical sciences and research |
| Address |
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
07388270452 |
| Fax |
|
| Email |
abha.gahlot@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abha Gahlot |
| Designation |
Professor |
| Affiliation |
school of medical sciences and research |
| Address |
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
Department of Ophthalmology, school of medical sciences and
research, plot no 32, 34, knowledge park 3, greater noida
UTTAR PRADESH
201310
India |
| Phone |
07388270452 |
| Fax |
|
| Email |
abha.gahlot@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research |
| Address |
Sharda hospital, plot no 32, 34, knowledge park 3, greater noida, 201310 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ankita Singh |
sharda hospital, school of medical sciences and research |
Department of Ophthalmology, ground floor, block C,
Gautam Buddha Nagar
UTTAR PRADESH |
07388270452
2023000936.ankita@pg.sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical prednisolone |
Postoperative 1 % prednisolone eye drops in preventing intraocular inflammation following phacoemulsification. |
| Intervention |
Subconjunctival triamcinolone acetonide injection |
Subconjunctival triamcinolone acetonide suspension 0.5 ml at a concentration of 40mg/ml injection given during cataract surgery for reducing post-operative intra-ocular inflammation. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients eligible for cataract surgery under peribulbar anesthesia.
2. Patients with uneventful cataract surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled diabetes mellitus, or glaucoma, patients with a prior history of uveitis, and patients on systemic anti-inflammatory treatment.
2. Patients with corneal diseases, infectious ocular lesions, and high myopes.
3. Patients with existing retinal abnormalities.
4. Patients with complicated cataract surgery and prior ocular surgery.
6. Patients with documented allergy to triamcinolone acetonide.
7. Patients not responding to SCTA injection given during surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of subconjunctival triamcinolone acetonide suspension 0.5 ml at a concentration of 40mg/ml injection given during cataract surgery for reducing post-operative intra-ocular inflammation. |
Day 1, 7, 30, 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of postoperative 1 % prednisolone eye drops in preventing intraocular inflammation following phacoemulsification. |
Day 1, 7, 30, 90 |
To compare the visual acuity, contrast sensitivity and steroid response, in cases of subconjunctival triamcinolone with the topical prednisolone eye drops in phacoemulsification.
|
Day 1, 7, 30, 90 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
29/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Cataract is the leading cause of blindness in India
constituting to 66.21% .
Regardless
of the etiology, surgery is the only treatment for cataracts that impair
vision. Despite the developments in equipment and techniques, complications can
still arise during and after surgery . Two of the most common
complications post cataract surgery are anterior segment inflammation and cystoid
macular edema
Post cataract
surgery topical drops such as non-steroidal anti-inflammatory drugs (NSAIDs) and
steroids have been the mainstay for prophylaxis and treatment of inflammation. In phacoemulsification, due to the small incision size, the
amount of inflammation is pretty mild and a non-steroid such as ketorolac can
handle it. Conventionally topical dexamethasone or prednisolone
is given in the post-operative period to reduce the inflammation. The safety
and efficacy of these drugs have been established in many studies. Sub-conjunctival triamcinolone acetonide (SCTA) depot offers a
therapeutic approach with a sustained anti-inflammatory effect. It can also
reduce complications resulting from patient’s non-compliance and inexperience with the use
of conventional eye drops. It is a moderate-strength
corticosteroid with a relatively long duration of action Its
efficacy is clinically equivalent to conventional 1% prednisolone eye drop in
reducing intra-ocular inflammation as measured by clinical method.
Intraocular
injections of steroids during cataract surgery, also known as drop-less surgery,
have become more popular as a technique that allows for less reliance on
postoperative drops without sacrificing outcomes for visual acuity or
inflammation control. In this procedure, steroid depot can be administered
in sub-tenons, intravitreal, or in subconjunctival space.
Although drop-less
cataract surgery has many benefits, only a few studies have examined the risk
of steroid response, the effectiveness, dose, safety, and
tolerability of a single perioperative SCTA injection in place of topical steroid
eye drops, as a part of the drop-less postoperative care protocol, for prevention
of intra-ocular inflammation post cataract surgery. |