None listed
Conditions
Brief summary
This study compares two commonly used clinical methods of tear film breakup time measurement. Participants from two age and gender matched groups, with and without dry eye disease, will be enrolled into a prospective, randomised, investigator-masked, crossover study. Two independent observers measured tear film breakup time in triplicate, respectively, in a randomised order, following fluorescein instillation under blue light, and using non-invasive automated Keratograph 5M readings. A 30-minute interval between measurements ensured subsidence of reflex tearing. The median and distribution of breakup time measurements will be compared, and Bland-Altman and Pearson correlation analysis will be conducted. A receiver operative characteristic curve will then be constructed to assess the diagnostic ability of the breakup time measurements in detecting whether subjects has dry eye disease.
Interventions
In this investigator-masked randomised crossover study, the tear film breakup time of participants will be assessed in triplicate, with and without sodium fluorescein instillation, in a randomised order, by two independent observers. A 30-minute interval between measurements will ensure subsidence of reflex tearing.
In the intervention arm, sodium fluorescein was applied to the bulbar conjunctiva from a fluorescein impregnated strip (Haag-Streit) wetted with 1 drop (10-20µl) of saline and shake
In this investigator-masked randomised crossover study, the tear film breakup time of participants will be assessed in triplicate, with and without sodium fluorescein instillation, in a randomised order, by two independent observers. A 30-minute interval between measurements will ensure subsidence of reflex tearing. In the intervention arm, sodium fluorescein was applied to the bulbar conjunctiva from a fluorescein impregnated strip (Haag-Streit) wetted with 1 drop (10-20µl) of saline and shaken to remove excess fluid. Following fluorescein instillation, participants were then instructed to blink naturally over a 1 minute period to facilitate even distribution over the ocular surface. Tear film breakup time was then assessed in triplicate under blue light with a Wratten yellow filter.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be enrolled into two age and gender matched groups, with and without symptomatic dry eye (Ocular Surface.Disease Index score greater than or equal to 13). Age of 18 years or older No history of major systemic disease. No history of ocular surgery. No use of topical or systemic medications known to affect the eye. Able to provide written informed consent
Exclusion criteria
Under 18 years of age. History of major systemic or ocular disease. History of ocular surgery. Current use of topical or systemic medications known to affect the eye.
Outcome results
None listed