| CTRI Number |
CTRI/2025/08/093513 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the cure rates of post-operative regime of topical medication (Moxifloxacin 0.5% and Prednisolone 1%) at 2 weeks and 6 weeks in cataract patients undergoing in uncomplicated Phacoemulsification. |
|
Scientific Title of Study
|
Comparison of the post-operative regime of topical medication in uncomplicated Phacoemulsification at 2 weeks and 6 weeks |
| 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 Shambhavi Jhobta |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8448841880 |
| Fax |
|
| Email |
shambhavijhobta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ram Lal Sharma |
| Designation |
Head Of Department |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418200098 |
| Fax |
|
| Email |
rls_10@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shambhavi Jhobta |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Department Of Ophthalmology,
11th floor , New OPD Block,
Indira Gandhi medical College and Hospital,
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8448841880 |
| Fax |
|
| Email |
shambhavijhobta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College and Hospital Shimla, H.P. - infrastructural support |
|
|
Primary Sponsor
|
| Name |
Dr Shambhavi Jhobta |
| Address |
Dept. of Ophthalmology,
11th floor New OPD block,
IGMC, Shimla, HP |
| Type of Sponsor |
Other [Self] |
|
|
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 Shambhavi Jhobta |
Indira Gandhi Medical college and Hospital |
Dept of ophthalmology,
11th floor New OPD BLOCK,
Indira Gandhi Medical College and Hospital, Shimla
Shimla
HIMACHAL PRADESH |
8448841880
shambhavijhobta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients receiving post operative treatment of Topical Moxifloxacin 0.5% and Prednisolone 1% combination for 2 weeks
|
Topical antibiotic with steroid combination drops (Moxifloxacin 0.5% and Prednisolone 1%)
given from 1st Post op day for 6 times per day till 1week followed by 4 times till 1 week [2 weeks] and patient will be put on ocular lubricant ( carboxy methyl cellulose) 4 times daily for the next 4 weeks.
Ointment antibiotic with steroid combination (Chloramphenicoln polymyxin-B sulphate & Dexamethasone) will be given at night time for 2 weeks.
|
| Comparator Agent |
Patients receiving post operative treatment of Topical Moxifloxacin 0.5% and Prednisolone 1% combination for 6 weeks |
Topical antibiotic with steroid combination drops (Moxifloxacin 0.5% and Prednisolone 1%)
given from 1st Post op day for 6 times per day till 2 week followed by 4 times till 2 week followed by 2 times per day for 2 weeks (6 weeks).
Ointment antibiotic with steroid combination (Chloramphenicol, polymyxin-B sulphate & Dexamethasone) will be given at night time for 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with cataract undergoing uncomplicated surgery (Phacoemulsification).
2. Patients who give consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with previous corneal disease, corneal trauma, or intraocular surgery.
2. Patients who had communication problems (short of hearing, language barriers, dementia, etc.).
3. Patients with glaucoma or uveitis
4. Patients with Diabetic Retinopathy, Hypertensive Retinopathy or any other macular disease
5. Use of ocular medication during or within 30 days prior to the enrollment.
6. Use of steroid during the study or within 14 days prior to enrollment.
7. Contraindication to ocular treatment with moxifloxacin and prednisolone
8. Systemic diseases that can interfere with the results of the study (e.g., rheumatoid arthritis, Sjögren’s syndrome, Behçet’s disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.);
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the post operative duration of topical medication from 6 weeks to 2 weeks. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Lesser postoperative side effects like secondary glaucoma, delayed healing & antibacterial resistance.
2. Better patient compliance
|
2 weeks & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 2 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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
|
This study is an interventional, single blind, randomized parallel group control trial that will be conducted in Indira Gandhi Medical College and Hospital, Shimla, H.P., India, comparing the cure rates of post-operative regime of topical medication ( Moxifloxacin 0.5% + Prednisolone1% ) at 2 weeks and 6 weeks in cataract patients undergoing uncomplicated Phacoemulsification. The study duration will be 1year (9 months of data collection and 3 months of data compilation and report writing). The primary end point will be the reduction in the post operative duration of topical medication from 6 weeks to 2 weeks. The secondary outcomes will be lesser postoperative side effects like secondary glaucoma, delayed healing and antibacterial resistance and better patient compliance. |