| CTRI Number |
CTRI/2023/04/051491 [Registered on: 11/04/2023] Trial Registered Prospectively |
| Last Modified On: |
10/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two antibiotics in cataract surgery prophylaxis. |
|
Scientific Title of Study
|
Topical ciprofloxacin 0.3% versus topical
moxifloxacin 0.5% as preoperative prophylaxis in cataract
surgery - a double-blinded non inferiority randomized, controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NIRUBAN G |
| Designation |
Assistant Professor, Ophthalmology, |
| Affiliation |
JIPMER, KARAIKAL |
| Address |
No: 77, Faculty hall,
Arasalar campus,Mathagadi
JIPMER, Karaikal
Karaikal
PONDICHERRY
609602
India |
| Phone |
|
| Fax |
|
| Email |
niruban@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NIRUBAN G |
| Designation |
Assistant Professor, Ophthalmology |
| Affiliation |
JIPMER, KARAIKAL |
| Address |
No:77, Faculty hall,
Arasalar campus,Mathagadi,
JIPMER, Karaikal
Karaikal
PONDICHERRY
609602
India |
| Phone |
|
| Fax |
|
| Email |
niruban@jipmer.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIRUBAN G |
| Designation |
Assistant Professor, Ophthalmology, |
| Affiliation |
JIPMER, KARAIKAL. |
| Address |
No.77, Faculty Hall,
Arasalar campus, Mathagadi,
JIPMER, Karaikal
Karaikal
PONDICHERRY
609602
India |
| Phone |
|
| Fax |
|
| Email |
niruban@jipmer.ac.in |
|
|
Source of Monetary or Material Support
|
| The Director,
JIPMER,
Dhanvanthri Nagar,
Puducherry,India |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,
DHANVANTHRI NAGAR,
PUDUCHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NIRUBAN G |
JIPMER KARAIKAL |
DEPARTMENT OF OPHTHALMOLOGY
ARASALAR CAMPUS
JIPMER, KARAIKAL
Karaikal
PONDICHERRY |
04368228075
niruban@jipmer.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES |
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 |
ciprofloxacin 0.3% |
Topical Ciprofloxacin 0.3% eye drops is used as a prophylactic drug in cataract surgery
one drop of this drug will be instilled in the eye at 2pm, 6pm, 10pm and 8 am in the 24 hrs preceding cataract surgery |
| Intervention |
Moxifloxacin 0.5% |
Topical Moxifloxacin eye drop is used as a prophylactic drug in cataract surgery instead of topical ciprofloxacin eye drop.
one drop of this drug will be instilled in the eye at 2pm, 6pm, 10pm and 8 am in the 24 hrs preceding cataract surgery. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 40 years of age who are enrolled for cataract surgery will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Ocular or systemic infection; 2. presence of ec-tropion, entropion, trichiasis or distichiasis; 3. usage of systemic or topical antibiotics or steroids within 30 days of enrolling in the study; 4. primary or sec-ondary immunocompromised patients; 5. debilitated patients; 6. chronic renal failure patients on dialysis; 7. patients allergic to iodine or fluoroquinolone anti-biotics; 8. inability to comprehend or unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of preoperative Ciprofloxacin compared to Moxifloxacin by assessing the difference in the proportion of eyes with negative bacterial cul-ture |
The first culture will be obtained before instilling the antibiotic drops (T0).Both the groups will receive antibiotic drops at 2pm, 6pm, 10pm and 8 am. An hour following the last antibiotic drop, a second conjunctival culture will be taken (T1). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of ciprofloxacin and moxi-floxacin on the bacterial isolates from conjunctival cultures.
To determine the clinical signs of infection in both group of patients postoperatively at one week and four weeks |
To determine the clinical signs of infection in both group of patients postoperatively at one week and four weeks |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
31/05/2023 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [niruban@jipmer.ac.in].
- For how long will this data be available start date provided 01-04-2024 and end date provided 31-03-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Patients will be randomized to either group A or group B by sealed envelope technique. A sterile conjunctival swab moistened in sterile saline will be used to take a conjunctival swab for all patients. All swabs will be rotated three times completely with slight pressure in the inferior conjunctival fornix without contacting the eyelids and eyelashes. They will be collected without instilling topical anaesthetic drops. The first culture will be obtained before instilling the antibiotic drops (T0). Group A patients will receive 0.3% ciprofloxacin eyedrops and group B patients will receive 0.5% moxifloxacin eye drops. Both the groups will receive antibiotic drops at 2pm, 6pm, 10pm and 8 am. An hour following the last antibiotic drop, a second conjunctival culture will be taken (T1). Participants in the study will be followed up at 1 week and 4 weeks postop for signs of infection (Best corrected visual acuity measured in feet by Snellen’s chart , lid edema, chemosis, hypopyon and vitritis) |