| CTRI Number |
CTRI/2024/10/074753 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Contact lens related changes in eyes |
|
Scientific Title of Study
|
Incidence of ocular microbial pathogens in contact lens users - Prospective Comparative study |
| 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 Anamika Kumari |
| Designation |
Secondary DNB Resident Doctor |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Sankara Eye Hospital, Ophthalmology department, Cornea division, room no. 28 Varthur Rd, Vaikuntam layout, Lakshminarayana Pura, Kundalhalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8210396981 |
| Fax |
|
| Email |
doctoranamika@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Joshi |
| Designation |
Cornea consultant |
| Affiliation |
Sankara Eye hospital, Bangalore |
| Address |
Sankara Eye Hospital, Ophthalmology department, cornea division, room no. 28 Varthur Rd, Vaikuntam layout, Lakshminarayana Pura, Kundalhalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Joshi |
| Designation |
Cornea consultant |
| Affiliation |
Sankara Eye hospital, Bnagalore |
| Address |
Sankara Eye Hospital, Ophthalmology department, cornea division, room no. 28 Varthur Rd, Vaikuntam layout, Lakshminarayana Pura, Kundalhalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Varthur main rd, Vaikuntam layout, Lakshminarayanapura, Kundalhalli, Munnekollal, Bengaluru, Karnataka, India 560037 |
|
|
Primary Sponsor
|
| Name |
Dr Anamika Kumari |
| Address |
Sankara Eye Hospital, Ophthalmology department, Cornea division, room no. 28 Varthur Rd, Vaikuntam layout, Lakshminarayana Pura, Kundalhalli, Munnekollal, Bengaluru |
| 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 Anamika Kumari |
Sankara Eye hospital, Bangalore |
Sankara Eye Hospital, Ophthalmology department, Cornea division, room no. 28 Varthur Rd, Vaikuntam layout, Lakshminarayana Pura, Kundalhalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA |
08210396981
doctoranamika@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H168||Other keratitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All contact lens users
Soft contact lenses (daily,monthly,bi weekly, yearly disposable) presenting either with contact lens related eye symptoms or asymptomatic |
|
| ExclusionCriteria |
| Details |
Pediatric patients
Patients not giving consent
Patients already using antibiotic eye drops in last 24 hours
Patients having blepharitis, conjunctivitis, episcleritis, scleritis, uveitis
Corneal dystrophy, post graft, recurrent corneal erosions
Hard contact lenses
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to detect presence of pathogenic organism in the eyes of symptomatic and asymptomatic CL wearer |
First OPD visit, 1 week later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any difference in growing organism & pattern of culture & sensitivity b/w symptomatic & asymptomatic CL wearer |
firs OPD. 1 week follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/10/2024 |
| 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
|
We will study the incidence of ocular microbial pathogens in contact lens users the study will help us in knowing the differential sensitivity in asymptomatic and symptomatic group and to evaluate the culture positivity and pattern of growth between the two groups which may help in preventive aspects of treatment guidelines |