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

NCT05754437 | Completed

• 1 other identifier: CatMask
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Low Level Light Therapy Group

EXPERIMENTAL

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).

Device: Low Level Light Therapy

Control group

NO INTERVENTION

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

Interventions

Low Level Light Therapy DEVICE

light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes

Low Level Light Therapy Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: lead

Study Sites (1)

Department of Ophthalmology, University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

Location

Related Publications (2)

• Giannaccare G, Borselli M, Rossi C, Carnovale Scalzo G, Pellegrini M, Vaccaro S, Scalia G, Lionetti G, Mancini A, Bianchi P, Scorcia V. Noninvasive screening of ocular surface disease in otherwise healthy patients scheduled for cataract surgery. Eur J Ophthalmol. 2024 Sep;34(5):1475-1480. doi: 10.1177/11206721241228621. Epub 2024 Jan 30.

  PMID: 38291650 DERIVED

• Giannaccare G, Rossi C, Borselli M, Carnovale Scalzo G, Scalia G, Pietropaolo R, Fratto B, Pellegrini M, Yu AC, Scorcia V. Outcomes of low-level light therapy before and after cataract surgery for the prophylaxis of postoperative dry eye: a prospective randomised double-masked controlled clinical trial. Br J Ophthalmol. 2024 Jul 23;108(8):1172-1176. doi: 10.1136/bjo-2023-323920.

  PMID: 37890879 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 3, 2023
• Study Start: March 30, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)