CTRI Number |
CTRI/2025/04/084964 [Registered on: 16/04/2025] Trial Registered Prospectively |
Last Modified On: |
12/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Single Arm Study |
Public Title of Study
|
Comparison between post op dropless treatment versus traditional with drop treatment |
Scientific Title of Study
|
A prospective, randomized, comparative clinical study to compare dropless cataract surgery regime and conventional post cataract treatment regime. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrSri Ganesh |
Designation |
Chief Medical Director |
Affiliation |
Nethradhama Super Speciality Eye Hospital |
Address |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru
Bangalore
KARNATAKA
Bangalore KARNATAKA 560070 India |
Phone |
9845129740 |
Fax |
|
Email |
phacomaverick@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Manasaveena N T |
Designation |
Phaco refractive surgery fellows |
Affiliation |
Nethradhama Super Speciality Eye Hospital |
Address |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru
Bangalore
KARNATAKA
Bangalore KARNATAKA 560070 India |
Phone |
9060630060 |
Fax |
|
Email |
manasa.veena2412@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr. Manasaveena N T |
Designation |
Phaco refractive surgery fellows |
Affiliation |
Nethradhama Super Speciality Eye Hospital |
Address |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru
Bangalore
KARNATAKA
KARNATAKA 560070 India |
Phone |
9060630060 |
Fax |
|
Email |
manasa.veena2412@gmail.com |
|
Source of Monetary or Material Support
|
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru, Karnataka, India, 560070
|
|
Primary Sponsor
|
Name |
Nethradhama Super Speciality Eye Hospital |
Address |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru
Bangalore
KARNATAKA |
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 |
DrManasaveenaNT |
Nethradhama Super Speciality Eye Hospital |
256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru
Bangalore
KARNATAKA Bangalore KARNATAKA |
9060630060
manasa.veena2412@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H258||Other age-related cataract, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
intracameral antibiotic and Sub-Tenon’s steriod injection immediate post op |
Sub-Tenon’s triamcinolone acetonide (12 mg/ml) and 0.1ml intracameral moxifloxacin (0.5%) (Auromox, Aurolab, India) administered at the end of surgery. |
Comparator Agent |
Traditional post op eye drop regimen |
Standard post-operative topical antibiotic-steroid regimen |
|
Inclusion Criteria
|
Age From |
50.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
Primary cataract surgery (age-related cataract) requiring phacoemulsification.
Patients with cataracts with nuclear opalescence grade 1-3, cortical cataract, posterior subcapsular cataract
Preoperative best-corrected visual acuity worse than 20/40.
No history of ocular trauma, glaucoma, diabetic retinopathy, or other retinal pathology.
|
|
ExclusionCriteria |
Details |
History of previous eye surgery (except for uncomplicated cataract surgery in the other eye).
Active ocular infection or inflammation (KNOWN CASE OF HSV OR RETROVIRAL/HEPATITIS) .
Systemic conditions contraindicating steroid use (e.g., active systemic infection, poorly controlled diabetes).
Complicated cataracts
History of uveitis, glaucoma, HIGH myopia.
Allergy to Triamcinolone Acetonide, Moxifloxacin, or any other components of the study drugs.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Best-Corrected Visual Acuity (BCVA) at postoperative day 1, 15 days, month 1, 3, and 6.
Intraocular Pressure (IOP) at postoperative day 1, 15 days, month 1, 3, and 6.
AC reaction (measured via anterior chamber cell count and flare according to SUN classification) - as measured on slit lamp.
OCT - macula- central sub retinal thickness (Optovue RTVue100, USA) - 15 days
|
postoperative days 1, 15, month 1, 3 and 6 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Rate of Postoperative Complications (e.g., endophthalmitis, posterior capsule opacification, macular edema, elevated IOP).
Patient Satisfaction (subjective questionnaire at 1 and 3 months).
Steroid Use: Number of patients requiring additional steroids.
|
postoperative days 1, 15, month 1, 3 and 6 |
|
Target Sample Size
|
Total Sample Size="320" Sample Size from India="320"
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)
|
23/04/2025 |
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 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 - NO
|
Brief Summary
|
Institutional
Ethics committee approval will be obtained and trial registered with Clinical
Trial Registry of India.
Patients
informed consent will be taken and the procedure explained to them in their own
language.
Study
design: Prospective, randomized, comparative, hospital-based, single center
interventional clinical study in patients with planned phacoemulsifiction
surgery.
Study
Setting: Nethradhama Superspeciality Eye Hospital, Bangalore.
Patient
selection criteria:
Patients
will be enrolled into the clinical study and randomized in a ratio of 1:1 by
simple random sampling through computer generated lottery method.
The
patients will also be willing to attend routine follow-up care as described
below (1 day up to 6 months post-surgery).
Study
Duration: Time frame for patient visits and examination are pre-operative, day
of surgery, postoperative days 1, 15, month 1, 3 and 6
Method of
data collection:
Data
will be collected on the demographic profile (age, gender, address, and
occupation) and ocular parameters of the patients, as measured by slit lamp
examination, 90D lens with slit lamp, and indirect ophthalmoscopy.
Before the
surgery, all patients will undergo a complete ophthalmic examination including
subjective refraction, slit lamp biomicroscopy, noncontact tonometry (Topcon
CT-80), dilated fundus examination, OCT macula. (Optovue RTVue 100, USA)
The
study participants will be divided into two groups –
Study
Group: Sub-Tenon’s triamcinolone acetonide (12 mg/ml) and 0.1ml intracameral
moxifloxacin (0.5%) (Auromox, Aurolab, India) administered at the end of
surgery.
Control
Group: Standard post-operative topical antibiotic-steroid regimen
Intervention
and Procedure:
Phacoemulsification
Surgery: All patients will undergo either standard phacoemulsification cataract
surgery or Femstosecond assisted laser assisted phacoemulsification by a single
surgeon. All procedures will be conducted under topical anesthesia.
Postoperative
Intervention:
|