The objective of the study is to evaluate the effectiveness of Low-level light therapy (LLLT) in combination with either topical Cyclosporine A (CsA) or topical Tacrolimus, using each non-steroidal immunosuppressant as an active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Three 15-minute sessions were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
CsA 0.1% twice per day
Tacrolimus 0.1% twice per day
Biomeeting Day Surgery center
Reggio Calabria, Calabria, Italy
Centro Oculistico Borroni
Gallarate, Varese, Italy
Ocular surface disease index (OSDI)
A standardized questionnaire designed to assess the symptoms of dry eye disease and their impact on vision-related functioning. It consists of 12 items that evaluate the frequency of symptoms, environmental triggers, and functional limitations over the previous week. The OSDI provides a score from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: From baseline visit to the end of follow-up (12 months)
Non-invasive tear film break-up time (NIBUT)
NIBUT is a clinical test used to evaluate tear film stability without the use of dyes. It measures the time interval between a complete blink and the first appearance of a disruption or break in the tear film. Shorter NIBUT values indicate reduced tear film stability.
Time frame: From baseline visit to the end of follow-up (12 months)
Tear meniscus height (TMH)
TMH is a quantitative parameter used to assess tear volume. Reduced TMH values are indicative of aqueous tear deficiency.
Time frame: From baseline visit to the end of follow-up (12 months)
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