Clinical trial NCT05754437: Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery
Official title: Effect of Low-Level Light Therapy Prior to Cataract Surgery: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 130
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* healthy patients affected by senile cataract
* patients scheduled for phacoemulsification and intraocular lens implantation

Exclusion Criteria:

* any other ocular comorbidity (e.g. glaucoma),
* chronic instillation of eye drops of any type
* previous ocular surgery or trauma to the addressed eye
* previous cataract surgery in the controlateral eye,
* active ocular infections
* use of systemic drug with a known or suspected link to dry eye (e.g. diuretics, antidepressants, antihistamines, hormone replacement therapy)
* autoimmune diseases (e.g. Sjögren syndrome)
* intraoperative complications (e.g. capsular bag rupture requiring vitrectomy, suprachoroidal hemorrhage)
* postoperative complications (e.g. endophthalmitis, vitritis)

Primary outcomes:
measure: Development or worsening of ocular surface abnormalities: tear meniscus height
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: bulbar redness
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: meibomian gland dropout
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular discomfort symptoms.
timeFrame: One week (±2 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: tear meniscus height
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: bulbar redness
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular surface abnormalities: meibomian gland dropout
timeFrame: One month (±7 days) after cataract surgery
measure: Development or worsening of ocular discomfort symptoms.
timeFrame: One month (±7 days) after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Department of Ophthalmology, University Magna Graecia of Catanzaro
Study officials:
References: