Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Status: Completed

Conditions: Dry Eye

Treatments: Device: Low Level Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05754437

CatMask

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Low Level Light Therapy Group

Experimental group

Description:

Patients enrolled in the treatment group will undergo Low Level Light therapy using Meibomask (Espansione Marketing S.p.A., Bologna, Italy) for 15 minutes one week (±2 days) before surgery (T0) and one week (±2 days) after surgery (T1).

Treatment:

Device: Low Level Light Therapy

Control group

No Intervention group

Description:

Patients enrolled in the control group will not receive Low Level Light therapy at any time.