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

Dry Eye Clinical Trial

Official title:

Effect of Low-Level Light Therapy Prior to Cataract Surgery: A Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754437
• Other study ID #: CatMask
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
• Contact: Giuseppe Giannaccare, MD, PhD, FEBOpth
• Phone: 003909613647135
• Email: giuseppe.giannaccare[@]unicz.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Low Level Light Therapy
light-emitting diodes (LED), ? = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes

Locations

Country	Name	City	State
Italy	Department of Ophthalmology, University Magna Graecia of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One week (±2 days) after cataract surgery
Primary	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.	One week (±2 days) after cataract surgery
Primary	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.	One week (±2 days) after cataract surgery
Primary	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.	One week (±2 days) after cataract surgery
Primary	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.	One week (±2 days) after cataract surgery
Primary	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	One week (±2 days) after cataract surgery
Primary	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	One week (±2 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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.	One month (±7 days) after cataract surgery
Primary	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	One month (±7 days) after cataract surgery