Back to resultsEfficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Low Level Light Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Dry Eye
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)
Sites / Locations
- Department of Ophthalmology, University Magna Graecia of CatanzaroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low Level Light Therapy Group
Control group
Arm 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).
Patients enrolled in the control group will not receive Low Level Light therapy at any time.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05754437
First Posted
January 31, 2023
Last Updated
March 2, 2023
Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
1. Study Identification
Unique Protocol Identification Number
NCT05754437
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Level Light Therapy Group
Arm Type
Experimental
Arm 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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients enrolled in the control group will not receive Low Level Light therapy at any time.
Intervention Type
Device
Intervention Name(s)
Low Level Light Therapy
Intervention Description
light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes
Primary Outcome Measure Information:
Title
Development or worsening of ocular surface abnormalities: tear meniscus height
Description
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Description
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.
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Description
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.
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Description
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.
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: bulbar redness
Description
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.
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Description
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
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular discomfort symptoms.
Description
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
Time Frame
One week (±2 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: tear meniscus height
Description
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Description
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.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Description
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.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Description
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.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: bulbar redness
Description
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.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Description
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.
Time Frame
One month (±7 days) after cataract surgery
Title
Development or worsening of ocular discomfort symptoms.
Description
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
Time Frame
One month (±7 days) after cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Giannaccare, MD, PhD, FEBOpth
Phone
003909613647135
Email
giuseppe.giannaccare@unicz.it
Facility Information:
Facility Name
Department of Ophthalmology, University Magna Graecia of Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Scorcia, MD
Phone
0039 09613647041
Email
vscorcia@unicz.it
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery
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