| CTRI Number |
CTRI/2025/02/079973 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of contact lens complication in a Tertiary eye hospital |
|
Scientific Title of Study
|
Prevalence of contact lens complication in Tertiary eye hospital at Bangalore |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanila Lawrance |
| Designation |
M.optom,FIACLE,Assistant professor sankara college of optometry |
| Affiliation |
sankara college of optometry bangalore |
| Address |
Sankara eye hospital and Sankara college of optometry
2nd floor kundanahalli gate varthur road bangalore -560037
Bangalore
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanila Lawrance |
| Designation |
M.optom,FIACLE,Assistant professor sankara college of optometry |
| Affiliation |
sankara college of optometry bangalore |
| Address |
Sankara Eye Hospital and Sankara college of Optometry Bangalore 2nd floor Kundanahalli gate Varthur road Bangalore-560037
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanila Lawrance |
| Designation |
M.optom,FIACLE,Assistant professor sankara college of optometry |
| Affiliation |
sankara college of optometry bangalore |
| Address |
Sankara eye hospital and Sankara college of optometry Bangalore -560037
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
|
Source of Monetary or Material Support
|
| sankara eye hospitals Kundanahalli gate Varthur main road Bangalore 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara eye hospital |
| Address |
Kundalahalli gate Varthur main road bangalore 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Pallavi Joshi |
Sankara eye hospital |
2nd floor, kundanahalli gate varthur main road bangalore 560037
Bangalore
KARNATAKA |
8762694607
pallavijoshi@sankaraeye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sankara eye hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
n/a |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
15-55 years |
|
| ExclusionCriteria |
| Details |
Corneal pathology other than contact lens related. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of CL complication and associated factors |
Baseline data is collected from the records at the first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| understanding the association of CL complication to type of lenses & complaints |
Baseline data is collected from the records at the first visit |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In this retrospective review, we will analyze the prevalence of contact lens complications, identifying common issues, risk factors, and preventive measures. Data will be collected from MRD and by using excel analysis will be made. The findings will provide insights to improve contact lens safety and eye health, helping reduce complications and enhance user experience. |