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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  
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 
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  
Status 
Not Applicable 
 
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:

 

 

 
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