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Comparing two methods of measuring tear film stability in dry eye patients

Comparison of fluorescein tear film breakup time with non invasive tear fim breakup time using Lacridiag in patients with dry eye - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/095628
Enrollment
50
Registered
2025-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H049- Disorder of lacrimal system, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil

Sponsors

Niranjana P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: BOTH TESTS ARE ASSESSED IN SAME DAY ONE AFTER OTHER

Secondary

MeasureTime frame
To evaluate the diagnostic accuracy of NITBUT, using FTBUT as the clinical reference standard. To assess reproducibility of NITBUT measurements using LacriDiag Timepoint: 9 months

Countries

India

Contacts

Public ContactRAJESH PRABU V

Sankara Eye Hospital, Coimbatore

drrajeshprabu@yahoo.com9442522373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026