| CTRI Number |
CTRI/2025/10/095628 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two methods of measuring tear film stability in dry eye patients |
|
Scientific Title of Study
|
Comparison of fluorescein tear film breakup time with non invasive tear fim breakup time using Lacridiag in patients with dry eye |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRANJANA P |
| Designation |
1 st year Post DO DNB Postgraduate |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
16-A, Sathy Road, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore, Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9496329980 |
| Fax |
|
| Email |
niranjanapreethy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJESH PRABU V |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
16-A, Sathy Road, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore, Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442522373 |
| Fax |
|
| Email |
drrajeshprabu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJESH PRABU V |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
16-A, Sathy Road, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore, Tamil Nadu 641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442522373 |
| Fax |
|
| Email |
drrajeshprabu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Niranjana P |
| Address |
16-A, Sathy Rd, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore, Tamil Nadu 641035 |
| 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 Niranjana P |
Sankara Eye Hospital |
1 st year Poat DO DNB Postgraduate
SATHY ROAD, SIVANANDAPURAM, COIMBATORE – 641035
Coimbatore
TAMIL NADU |
9496329980
niranjanapreethy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18 years and above of both sexes
2.Patients with symptoms suggestive of dry eye (burning, grittiness, foreign body sensation, photophobia etc).
3.Positive Ocular Surface Disease Index (OSDI) score more than 13.
4.Willingness to give informed consent and undergo tests |
|
| ExclusionCriteria |
| Details |
1.History of ocular surgery or trauma in the past 6 months.
2.Presence of active ocular infection, inflammation or allergy.
3.Patients unable to cooperate with diagnostic procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between Non-Invasive Tear Film Break-Up Time (NITBUT) measured by LacriDiag® and the Fluorescein Tear Film Break-Up Time (FTBUT) in patients diagnosed with dry eye disease. |
BOTH TESTS ARE ASSESSED IN SAME DAY ONE AFTER OTHER |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the diagnostic accuracy of NITBUT, using FTBUT as the clinical reference standard.
To assess reproducibility of NITBUT measurements using LacriDiag
|
9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/10/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dry Eye
Disease (DED) is a common ocular condition characterized by tear film
instability, causing discomfort and visual disturbance.
The
conventional method, Fluorescein TBUT (FTBUT), though widely used, is invasive
and can induce reflex tearing, affecting accuracy.
To address
these limitations, Noninvasive TBUT using devices like Lacridiag has been
developed.
Principle:
A Placido disc projects concentric rings on the cornea.
The
stability of the tear film assessed by monitoring distortion or break-up of
these rings over time.
Longer
NITBUT suggests stable tear film, while a short NITBUT suggests
instability.
In this
study we are comparing invasive TBUT vs Noninvasive TBUT.
|