Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title:

Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904874
• Other study ID #: 02282021065726
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2021
• Source: Dar Al Shifa Hospital
• Contact: Magda Torky
• Phone: 0096594492487
• Email: magda_turkey[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• age of at least 20 years.

• The diagnosis of obstructive MGD based on ocular symptoms, plugged gland ori?ces, 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 ?ndings for at least 1 year before study treatment

Exclusion Criteria:

• the presence of active skin lesions, skin cancer, or other speci?c skin pathology.

• active ocular infection or ocular in?ammatory disease.

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• intense pulsed light
treatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks

Locations

Country	Name	City	State
Kuwait	Dar alshif hospital	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Dar Al Shifa Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Primary	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	6 months
Primary	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.	6 months