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CTRI Number  CTRI/2025/05/087123 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to see if using nepafenac 0.1 percentage eyedrop before cataract surgery helps in keeping pupil dilated during procedure and prevents in swelling in retina 
Scientific Title of Study   Study to evaluate effectiveness of prophylactic topical nepafenac 0.1 percentage in maintaining transoperative mydriasis and preventing post operative macular edema in topical phacoemulsification cataract surgery  
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 Srashti Jain 
Designation  Postgraduate student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Ophthalmology, Ground floor,AVBRH building, Sawangi,Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7389425924  
Fax    
Email  srashti.jain2801@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin Tidake 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Ophthalmology, Ground floor,AVBRH building, Sawangi,Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7887476011  
Fax    
Email  drpravinktidake75@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravin Tidake 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Ophthalmology, Ground floor,AVBRH building, Sawangi,Meghe


MAHARASHTRA
442001
India 
Phone  7887476011  
Fax    
Email  drpravinktidake75@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research , Sawangi, Wardha, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi, Wardha, India 442001 
Type of Sponsor  Private medical college 
 
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 
Dr Srashti jain  Acharya Vinobha Bhave Rural Hospital  Department of Ophthalmology,surgical unit ward,AVBRH building, Sawangi,Meghe
Wardha
MAHARASHTRA 
07389425924

srashti.jain2801@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control  without using Topical Nepafenac 0.1% preoperatively in patients undergoing phacoemulsification cataract surgery 
Intervention  Topical Nepafenac 0.1%  Using Topical Nepafenac 0.1% preoperatively in patients undergoing phacoemulsification cataract surgery  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Diagnosed with senile and/or metabolic cataract.
2. Scheduled for surgery by phacoemulsification.
3. patient With a normal fundoscopy exam, if observance was possible.
 
 
ExclusionCriteria 
Details  1. Pregnancy or breastfeeding.
2. History of ocular inflammatory or infectious eye disease.
3. Treatment for eye infection within 30 days prior to inclusion in the study.
4. Alterations on the eye surface, including dry eye.
5. History of ocular surgery and/or trauma.
6. Knowledge or suspicion of allergy or hypersensitivity to the preservatives, steroids, topical NSAIDs, or any other component of the study medication.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
We expect significant results/outcomes that in order to maintain transoperative mydriasis & avoid post-operative macular edema following cataract surgery, prophylactic tropical nepafenac is likely to be useful  Assessment will be done after one and half months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/06/2025 
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="2"
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  

Following standard cataract surgery, impairment of vision may result from post-operative cystoid macular oedema (CMO). The purpose of the research is to assess the efficacy of preventive topical nepafenac (0.1%) in preventing post-operative macular edema following phacoemulsified cataract surgery & in preserving transoperative mydriasis. This 2-year study where the patients reporting to the Department OPD of Ophthalmology, undergoing the phacoemulsification cataract surgery will be part of the research. The study include 38 patients (two groups) & the study type is prospective, randomized, single-masked comparative study. For topical mydriatic usage, each treatment group will receive two doses of tropicamide 0.8% & phenylephrine 5% every fifteen minutes. Moreover, the nepafenac group received 4 doses starting an hour before surgery at a rate of only one drop once every fifteen minutes. Following surgery, all patients had a 4-week tapering period after receiving topical corticosteroid-antibiotic therapy (prednisolone + moxifloxacin) once for one hour for 15 days. One drop of nepafenac will be administered three times a day to the participants in the group being studied (the nepafenac group) starting the day before surgery & continued for six weeks following. Postoperative evaluations will be performed on the first day & Weeks 2 & 6 after surgery for all patients. Significant findings in the effectiveness of prophylactic tropical nepafenac is expected in the maintenance of transoperative mydriasis & prevention of post operative macular edema in the cataract surgery.

 
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