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Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

Primary Purpose

Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
laser light
Sponsored by
Naval Hospital, Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry eye, meibomian gland dysfunction, laser

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years
  • chief complaint of more than one of dryness, foreign-body sensation, burning, and tearing for 3 months
  • diagnosis of MGD with palpebral telangiectasia in both eyes

Exclusion Criteria:

  • ocular structural abnormalities
  • history of ocular trauma or surgery
  • use of any treatment for DE or MGD, other than artificial tears, within the past month
  • active allergy, infection, or inflammatory disease at the ocular surface unrelated to DE or MGD
  • lacrimal drainage-system anomalies
  • contact-lens wear
  • use of any systemic anti-inflammatory medicine

Sites / Locations

  • Naval Hospital of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treated

Untreated

Arm Description

The lower eyelid margin of the clinically worse eye was selected for treatment. A slit lamp based 532 nm optically pumped dual diode solid state SP-Mode (subthreshold) laser system was used. After cleaning eyelids with a cosmetic face wash, a drop of proparacaine hydrochloride 0.5% was then administered onto the conjunctival sac. No eye or cornea shield was used, since laser light was directly aimed at telangiectasias. The treatment parameters were set with 50 μm spot size and 200 ms duration with 30% duty cycle. The power ranged from 1500 to 1700 mW with monospot micropulse model and a just visible destruction of the telangiectatic vessels served as the threshold burn. After the procedure, the patient received corticosteroid ointment for 5 days on both eyes and was advised to continue applying her pre-treatment medication on both eyes.

The lateral eye was observed as control.

Outcomes

Primary Outcome Measures

Change from Baseline Lower Eyelid Margin Vascularity
Lower Eyelid Margin Vascularity is measured with ImageJ® software for vessels analysis from photographs of lower eyelid margin. Vascularity is evaluated as percentage (%) of lower eyelid margin surface. Time points are referred at ''Time Frame'' section.

Secondary Outcome Measures

Ocular Surface Disease Index (OSDI)
scale (0-100). Higher values represent greater disability.
Tear Break Up Time (TBUT)
time (seconds). Higher values represent greater disability.
Lower Eyelid Tear Meniscus Height
height (μm)
Meibomography
scale (0,1,2,3). Higher values represent greater disability.

Full Information

First Posted
June 4, 2020
Last Updated
June 6, 2020
Sponsor
Naval Hospital, Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04425551
Brief Title
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
Official Title
Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Naval Hospital, Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed. Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects. This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction
Keywords
dry eye, meibomian gland dysfunction, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant's clinically worse eye was selected for treatment, while the other eye was observed as control. If both eyes were clinically same, one of them was randomly selected. *Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Active Comparator
Arm Description
The lower eyelid margin of the clinically worse eye was selected for treatment. A slit lamp based 532 nm optically pumped dual diode solid state SP-Mode (subthreshold) laser system was used. After cleaning eyelids with a cosmetic face wash, a drop of proparacaine hydrochloride 0.5% was then administered onto the conjunctival sac. No eye or cornea shield was used, since laser light was directly aimed at telangiectasias. The treatment parameters were set with 50 μm spot size and 200 ms duration with 30% duty cycle. The power ranged from 1500 to 1700 mW with monospot micropulse model and a just visible destruction of the telangiectatic vessels served as the threshold burn. After the procedure, the patient received corticosteroid ointment for 5 days on both eyes and was advised to continue applying her pre-treatment medication on both eyes.
Arm Title
Untreated
Arm Type
No Intervention
Arm Description
The lateral eye was observed as control.
Intervention Type
Procedure
Intervention Name(s)
laser light
Intervention Description
laser light destruction of telangiectatic vessels of lower eyelid margin via selective thermolysis
Primary Outcome Measure Information:
Title
Change from Baseline Lower Eyelid Margin Vascularity
Description
Lower Eyelid Margin Vascularity is measured with ImageJ® software for vessels analysis from photographs of lower eyelid margin. Vascularity is evaluated as percentage (%) of lower eyelid margin surface. Time points are referred at ''Time Frame'' section.
Time Frame
Baseline, Day 0 after treatment, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
scale (0-100). Higher values represent greater disability.
Time Frame
Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Title
Tear Break Up Time (TBUT)
Description
time (seconds). Higher values represent greater disability.
Time Frame
Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Title
Lower Eyelid Tear Meniscus Height
Description
height (μm)
Time Frame
Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Title
Meibomography
Description
scale (0,1,2,3). Higher values represent greater disability.
Time Frame
Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years chief complaint of more than one of dryness, foreign-body sensation, burning, and tearing for 3 months diagnosis of MGD with palpebral telangiectasia in both eyes Exclusion Criteria: ocular structural abnormalities history of ocular trauma or surgery use of any treatment for DE or MGD, other than artificial tears, within the past month active allergy, infection, or inflammatory disease at the ocular surface unrelated to DE or MGD lacrimal drainage-system anomalies contact-lens wear use of any systemic anti-inflammatory medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Kappos, MD
Organizational Affiliation
Naval Hospital, Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Hospital of Athens
City
Athens
ZIP/Postal Code
11521
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

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