| CTRI Number |
CTRI/2025/04/084740 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of pre-operative antibiotic eye drops on conjuntival bacterial flora in preoperative cataract surgery patients |
|
Scientific Title of Study
|
To assess the effect of topical ofloxacin combination of topical ofloxacin and topical povidine iodine on conjuntival flora in preoperative cataract surgery patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Elizabeth Varghese |
| Designation |
post graduate student department of ophthalmology |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
post graduate student in ophthalmology Sri Ramachandra Medical College and research institute Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9544101109 |
| Fax |
|
| Email |
dezvrindavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prof Stephen Sudhakar |
| Designation |
professor department of ophthalmology |
| Affiliation |
professor department of ophthalmology Sri Ramachandra Medical College and Research Institute |
| Address |
Dr Stephen Sudhakar department of ophthalmology Sri Ramachandra Medical College and research institute Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9944025350 |
| Fax |
|
| Email |
stephensudhakar8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Elizabeth Varghese |
| Designation |
post graduate student department of ophthalmology |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
room 545 Girls hostel 5 Sri Ramachandra Medical College and research institute Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9544101109 |
| Fax |
|
| Email |
dezvrindavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institue Porur Chennai India pincode 600116 |
|
|
Primary Sponsor
|
| Name |
Divya Elizabeth Varghese |
| Address |
Room 545 Girls hostel 5 Sri Ramachandra Medical College and research institute Porur Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ProfStephen Sudhakar |
Professor,senior consultant, neuro-ophthalmology , department of ophthalmology , SRIHER , Porur, Chennai - 600116 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divya Elizabeth Varghese |
Sri Ramachandra Medical College and Research Institute |
G block Department of Ophthalmology Sri Ramachandra Medical College and Research Institute Porur Chennai
Chennai
TAMIL NADU |
9544101109
dezvrindavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD 10 PCS 3E0C3GC administration of topical ofloxacin and topical povidone iodine |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
eye drops ofloxacin (0.3%) group |
ofloxacin eye drops (0.3%) are applied three times a day for three days preoperatively in both eyes of patients admitted for cataract surgery. Conjunctival swab is taken on the day of surgery (under strict aseptic precautions) and send for culture |
| Intervention |
combination of eyedrops ofloxacin (0.3%) and povidine iodidne (5%) group |
applying eyedrops ofloxacin (0.3%) in both eyes for three times a day for three days and eye drops povidine iodidne (5%) in both eyes for three days preoperative for patients admitted for cataract surgery. conjuntival swab is taken on the day of surgery under strict aseptic precautions and sent for culture |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Preoperative patients who are scheduled to undergo cataract surgery
2.Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with any signs of ocular infection / adnexal infection
2. Patients with history of use of focal/systemic antibiotics within 2 months prior to 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 |
| Comparing the efficacy of antibiotic and combination of antibiotic and povidone iodine on reducing the conjunctival bacterial flora |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2) To assess ofloxacin sensitivity on conjunctival bacterial flora in preoperative cataract patients |
1 WEEK TO 2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/04/2025 |
| 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 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
|
A total of 120 eyes from 120 patients will be enrolled in this prospective randomized study After obtaining Institutional Ethics Committee approval, patients fitting in to the inclusion criteria will be taken for the study after obtaining patient’s informed consent. Demographic information will be gathered along with the clinical history. One single skilled ophthalmologist will do a thorough visual examination that includes: Best corrected visual acuity as measured by the Snellen chart converted to the Log MAR chart Slit lamp examination of the anterior segment After pupillary dilatation with 0.8 percentage Tropicamide and 5 percentage Phenylephrine eye drops fundoscopic examination using an indirect ophthalmoscope with a 20 D lens and slit lamp biomicroscopy with a 78 D lens is performed . The Excel software program will be used to generate random numbers that will be assigned to each patient (block randomization). Patients will then be randomly assigned to either group 1 having 60 eyes or group 2 having 60 eyes Group 1 receiving ofloxacin eye drops Group 2 receiving ofloxacin and povidone iodine eye drops. All eyes will recieve 1 drop of 0.3% topical ofloxacin for a total of 3 applications per day beginning from the day of admission to the day of surgery In addition the eyes in group 2 will recieve 1 drop of topical povidone iodine 1 time a day beginning from the day of admission(day0) to the day of surgery (day 2/3) Conjunctival swab will be obtained from either groups on the day of admission (day 0) and on the day of surgery ( day2/3 ) by swabbing inferior conjunctival fornix The collected material will be inoculated into thioglycolate broth and petridish with solid culture medium like blood agar , chocolate agar and macconkey agar and spread with a platinum wire in lines covering all surface of the plate. The procedure allowed to isolate colonies. The plates will then be incubated for 24-48 hours presence of bacterial growth will be checked for 2 days Ofloxacin sensitivity of the conjunctival bacterial flora will also be assessed by plating the collected material into media with ofloxacin antibiotic disc. Area of clareance of bacterial colony around the antibiotic disc will be noted |