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Intense Regulated Pulsed Light vs Warm Compresses for Meibomian Gland Dysfunction
N/A
Recruiting
Led By James Wolffsohn, PhD
Research Sponsored by Aston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following: OSDI score >13 and NITBUT <= 10sec
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and day 75
Awards & highlights
Study Summary
This trial is testing a new way to treat a common eye condition, and comparing it to the current standard of care.
Who is the study for?
This trial is for individuals with symptoms of dry eye due to Meibomian Gland Dysfunction, who have an OSDI score over 13 and a tear breakup time of 10 seconds or less. Participants must not have used certain eye medications or treatments recently and should not have severe gland loss or other conditions that could affect the study.Check my eligibility
What is being tested?
The study compares E>EYE intense regulated pulsed light (IRPL) treatment against the standard warm compress therapy for treating Meibomian Gland Dysfunction. It aims to determine which method is more effective in managing symptoms associated with evaporative Dry Eye disease.See study design
What are the potential side effects?
While specific side effects are not listed, IRPL treatments may cause discomfort, redness, or temporary changes in vision. Warm compresses are generally safe but can sometimes lead to mild irritation around the eyes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms of dry eye due to meibomian gland dysfunction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline and day 75
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and day 75
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptoms of dry eye disease
Tear film stability
Secondary outcome measures
Eye redness
Lipid layer thickness
Meibomian gland patency
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IRPLExperimental Treatment1 Intervention
Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45
Group II: Warm compressActive Control1 Intervention
Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes
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Who is running the clinical trial?
Aston UniversityLead Sponsor
37 Previous Clinical Trials
7,845 Total Patients Enrolled
2 Trials studying Meibomian Gland Dysfunction
48 Patients Enrolled for Meibomian Gland Dysfunction
James Wolffsohn, PhDPrincipal InvestigatorAston University
2 Previous Clinical Trials
78 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have eye makeup on your eyelids within the last 10 minutes before the study testing.I have chronic dry eye or Sjogren's syndrome, with no other eye or systemic conditions.I haven't used warm compresses or any lid warming treatments in the last 6 months.I have lost more than 75% of my meibomian glands.I have used prescription eye drops in the last 24 hours.I have not used artificial tears within 2 hours before the study tests.I have symptoms of dry eye due to meibomian gland dysfunction.
Research Study Groups:
This trial has the following groups:- Group 1: IRPL
- Group 2: Warm compress
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently engaged in this research study?
"Affirmative, the information on clinicaltrials.gov displays that this medical study is actively recruiting volunteers. The research was initially posted on June 8th of 2021 and modified most recently on July 19th 2022. At present, 50 participants are being recruited from one site."
Answered by AI
What are the potential outcomes of this investigation?
"This research trial seeks to evaluate the efficacy of a treatment by measuring its impact on dry eye disease symptoms. Secondary outcomes evaluated include changes in Meibomian gland patency, tear volume (measured in millimeters), and lipid layer thickness (graded against Guillon's standardised categories). Results are expected at Day 75 following baseline observations."
Answered by AI
Are researchers actively enrolling participants in this investigation?
"Affirmative, current evidence on clinicaltrials.gov demonstrates that this trial is currently enrolling patients. Postings for the study commenced on June 8th 2021 and have recently been updated on July 19 2022. The research aims to recruit 50 individuals from a single centre."
Answered by AI
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