Intense Pulsed Light in Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Intense Pulsed Light therapy
Sham Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Age older than 18 years
- Presence of meibomian gland dysfunction at any stage
- Presence of meibomian glands on each lower eyelid's Meibography
Exclusion Criteria:
- Fitzpatrick Skin Type VI
- Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
- Usage of systemic antibiotic therapy
- Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- Ocular surgery within prior 3 months
- Ocular injury within prior 3 months
- Ocular herpes of eye or eyelid within prior 3 months
- Active ocular infection
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- Eyelid abnormalities that affect lid function
- Ocular surface abnormality that may compromise corneal integrity
- Pregnancy
Sites / Locations
- Vienna Institute for Research in Ocular SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Study eyes
Control eyes
Arm Description
Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations).
The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.
Outcomes
Primary Outcome Measures
Difference Meibum quality score and expressibility between both eyes during the 6-month visit
Secondary Outcome Measures
Comparison of dry eye related parameters between both eyes (tear film break up time, Oxford Staining)
Change of dry eye related parameters during the study period in the study eye (tear film break up time, Oxford Staining)
Change of Ocular Surface Disease Index (OSDI) score during the study period
Full Information
NCT ID
NCT05089591
First Posted
October 20, 2021
Last Updated
October 20, 2021
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT05089591
Brief Title
Intense Pulsed Light in Meibomian Gland Dysfunction
Official Title
Efficacy of Intense Pulsed Light Treatment in Patients With Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Meibomian gland dysfunction (MGD) is a major cause of dry eye disease (DED). Up to 86% of patients suffering from DED also show signs of MGD. Traditional treatment of MGD is based on eye lid hygiene and massage in combination with intensive usage of lubricants.
Recently, a novel technology the intense pulsed light (IPL) therapy was introduced, which shows promising results in patients with meibomian gland dysfunction. Originating from field of dermatology, subjecting improvement of dry eye symptoms was recognized after the treatment of facial rosacea using IPL. Different hypotheses exist how IPL treatment might improve the situation in the dry eye patient. Warming of the eyelid, due to the light application and reduction of bacterial load are two possible mode of actions. Further, the used wavelengths in IPL may be modified that the light is only absorbed by oxygenated haemoglobin, which lead to an obliteration of telangiectasia and reduced inflammation on the lid margin. This principal is applied in the treatment of facial rosacea.
Aim of this study is to investigate the effect of IPL therapy in patients with MGD on dry eye parameters as well as subjective complaints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Bilateral comparison
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study eyes
Arm Type
Active Comparator
Arm Description
Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations).
Arm Title
Control eyes
Arm Type
Sham Comparator
Arm Description
The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light therapy
Intervention Description
The LacryStim System is a CE marked device for treatment of meibomian gland dysfunction. It stimulates and reactivates meibomian glands and improves the related dry eye condition. Intense pulsed light is emitted with a light spectrum from 610nm to 1200nm. Each treatment consists of short individual pulses lasting for 4ms separated by a 26ms lasting interval to hinder tissue temperature increase, thermal damage to the skin and inflammatory reaction. During this phase 8 to 12 J / cm2 are delivered. Selection of total energy levels depends on the skin type (Fitzpatrick Skin Types) as recommended by the manufacturer.
Intervention Type
Device
Intervention Name(s)
Sham Treatment
Intervention Description
The fellow eye serves as the control eye. Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations). The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.
Primary Outcome Measure Information:
Title
Difference Meibum quality score and expressibility between both eyes during the 6-month visit
Time Frame
6-months visit
Secondary Outcome Measure Information:
Title
Comparison of dry eye related parameters between both eyes (tear film break up time, Oxford Staining)
Time Frame
6 months
Title
Change of dry eye related parameters during the study period in the study eye (tear film break up time, Oxford Staining)
Time Frame
6 months
Title
Change of Ocular Surface Disease Index (OSDI) score during the study period
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age older than 18 years
Presence of meibomian gland dysfunction at any stage
Presence of meibomian glands on each lower eyelid's Meibography
Exclusion Criteria:
Fitzpatrick Skin Type VI
Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
Usage of systemic antibiotic therapy
Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
Ocular surgery within prior 3 months
Ocular injury within prior 3 months
Ocular herpes of eye or eyelid within prior 3 months
Active ocular infection
Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
Eyelid abnormalities that affect lid function
Ocular surface abnormality that may compromise corneal integrity
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Palkovits, MD, PhD
Phone
+43 (0)1 91021- 57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Schlatter, MD
Phone
+43 (0)1 91021- 57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, FEBO
Phone
+43 (0)1 91021- 57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intense Pulsed Light in Meibomian Gland Dysfunction
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