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Completed

NCT Number: NCT05754437

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low Level Light Therapy

Device

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

Primary outcomes

  1. Development or worsening of ocular surface abnormalities: tear meniscus height

    Time frame: One week (±2 days) after cataract surgery

    Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.

  2. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST

    Time frame: One week (±2 days) after cataract surgery

    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.

  3. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG

    Time frame: One week (±2 days) after cataract surgery

    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.

  4. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS

    Time frame: One week (±2 days) after cataract surgery

    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.

  5. Development or worsening of ocular surface abnormalities: bulbar redness

    Time frame: One week (±2 days) after cataract surgery

    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.

  6. Development or worsening of ocular surface abnormalities: meibomian gland dropout

    Time frame: One week (±2 days) after cataract surgery

    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

  7. Development or worsening of ocular discomfort symptoms.

    Time frame: One week (±2 days) after cataract surgery

    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

  8. Development or worsening of ocular surface abnormalities: tear meniscus height

    Time frame: One month (±7 days) after cataract surgery

    Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.

  9. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST

    Time frame: One month (±7 days) after cataract surgery

    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.

  10. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG

    Time frame: One month (±7 days) after cataract surgery

    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.

  11. Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS

    Time frame: One month (±7 days) after cataract surgery

    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.

  12. Development or worsening of ocular surface abnormalities: bulbar redness

    Time frame: One month (±7 days) after cataract surgery

    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.

  13. Development or worsening of ocular surface abnormalities: meibomian gland dropout

    Time frame: One month (±7 days) after cataract surgery

    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.

  14. Development or worsening of ocular discomfort symptoms.

    Time frame: One month (±7 days) after cataract surgery

    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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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