Back to resultsIntense Pulsed Light Therapy in Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
intense pulsed light
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
- age of at least 20 years.
- The diagnosis of obstructive MGD based on ocular symptoms, plugged gland orifices, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure).
- failure of at least 3 types of conventional MGD therapy to improve symptoms or objective findings for at least 1 year before study treatment
Exclusion Criteria:
- the presence of active skin lesions, skin cancer, or other specific skin pathology.
- active ocular infection or ocular inflammatory disease.
Sites / Locations
- Dar alshif hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
flourescein staining, miboscore
Arm Description
Outcomes
Primary Outcome Measures
Tear film break up time (TBUT)
After instillation of fluorescein in the conjunctival sac with fluorescein sodium strips (Jingming New TechnologicalDevelopment Co Ltd, Tianjin, China), the subject was asked to blink several times. Then, the tear film was observed under the slitlamp, using a cobalt blue filter to increase the visual contrast. For each eye, TBUT was evaluated three consecutive times, and the average of these three measurements was calculated and taken for the analysis.TBUT, a cut-off value of 5 sec was used to distinguish between moderate/severe TBUT (#5 sec) and mild/normal TBUT (.5 sec)
schirmmer staining
doctor places a piece of filter paper inside the lower eyelid of both eyes and the person closes their eyes.
After 5 minutes, the doctor removes the filter paper. The doctor then assesses how far the tears have travelled on the paper. Result under 10 mm is considered to be an abnormally low level of tear production
Standard Patient Evaluation of Eye Dryness (SPEED)questionnaire
the self evaluated Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (Tear Science, Morrisville, VC). This validated questionnaire asked the subject to grade the frequency and severity of four symptoms categories: (1) dryness, grittiness or scratchiness; (2) soreness or irritation; (3) burning or watering; and (4) eye fatigue. For each of these symptom categories, the subject subscored the frequency using a 4-point scale (0 never, 1 sometimes, 2 often, 3 constant), and subscored the severity using a 5-point scale (0 none, 1 tolerable, 2 uncomfortable, 3 bothersome, 4 intolerable). The SPEED score was calculated as the sum of these eight subscores. A SPEED score of 10 is widely accepted as indicating severe DED symptoms, and a cut-off value around six is often used to distinguish between asymptomatic/mild and moderate/severe symptoms.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904874
Brief Title
Intense Pulsed Light Therapy in Meibomian Gland Dysfunction
Official Title
Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dar Al Shifa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
flourescein staining, miboscore
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
intense pulsed light
Intervention Description
treatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks
Primary Outcome Measure Information:
Title
Tear film break up time (TBUT)
Description
After instillation of fluorescein in the conjunctival sac with fluorescein sodium strips (Jingming New TechnologicalDevelopment Co Ltd, Tianjin, China), the subject was asked to blink several times. Then, the tear film was observed under the slitlamp, using a cobalt blue filter to increase the visual contrast. For each eye, TBUT was evaluated three consecutive times, and the average of these three measurements was calculated and taken for the analysis.TBUT, a cut-off value of 5 sec was used to distinguish between moderate/severe TBUT (#5 sec) and mild/normal TBUT (.5 sec)
Time Frame
6 months
Title
schirmmer staining
Description
doctor places a piece of filter paper inside the lower eyelid of both eyes and the person closes their eyes.
After 5 minutes, the doctor removes the filter paper. The doctor then assesses how far the tears have travelled on the paper. Result under 10 mm is considered to be an abnormally low level of tear production
Time Frame
6 months
Title
Standard Patient Evaluation of Eye Dryness (SPEED)questionnaire
Description
the self evaluated Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (Tear Science, Morrisville, VC). This validated questionnaire asked the subject to grade the frequency and severity of four symptoms categories: (1) dryness, grittiness or scratchiness; (2) soreness or irritation; (3) burning or watering; and (4) eye fatigue. For each of these symptom categories, the subject subscored the frequency using a 4-point scale (0 never, 1 sometimes, 2 often, 3 constant), and subscored the severity using a 5-point scale (0 none, 1 tolerable, 2 uncomfortable, 3 bothersome, 4 intolerable). The SPEED score was calculated as the sum of these eight subscores. A SPEED score of 10 is widely accepted as indicating severe DED symptoms, and a cut-off value around six is often used to distinguish between asymptomatic/mild and moderate/severe symptoms.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of at least 20 years.
The diagnosis of obstructive MGD based on ocular symptoms, plugged gland orifices, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure).
failure of at least 3 types of conventional MGD therapy to improve symptoms or objective findings for at least 1 year before study treatment
Exclusion Criteria:
the presence of active skin lesions, skin cancer, or other specific skin pathology.
active ocular infection or ocular inflammatory disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magda Torky
Phone
0096594492487
Email
magda_turkey@yahoo.com
Facility Information:
Facility Name
Dar alshif hospital
City
Kuwait
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magda torky
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intense Pulsed Light Therapy in Meibomian Gland Dysfunction
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