| 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
|
|
|
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
|
|
|
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. |