The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery. Participants will be randomly assigned in a 1:1 ratio to either a treatment group or a control group. The treatment group will receive LLLT one week before and one week after cataract surgery; the control group will not recieve LLLT at any time. Researchers will compare the treatment and the control group to see if patients receiving LLLT present with reduced signs and symptoms of ocular surface dysfunction with respect to the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes
Department of Ophthalmology, University Magna Graecia of Catanzaro
Catanzaro, Italy
Development or worsening of ocular surface abnormalities: tear meniscus height
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT CLASS: classification incorporated in the instrument: class 0 \> 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III \< 3 s.Measurement expressed in seconds.
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: bulbar redness
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular discomfort symptoms.
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED \> 32
Time frame: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: tear meniscus height
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT CLASS: classification incorporated in the instrument: class 0 \> 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III \< 3 s.Measurement expressed in seconds.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: bulbar redness
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more.
Time frame: One month (±7 days) after cataract surgery
Development or worsening of ocular discomfort symptoms.
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED \> 32
Time frame: One month (±7 days) after cataract surgery
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