Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

Not Applicable

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: intense pulsed light

• Registration Number: NCT04904874
• Lead Sponsor: Dar Al Shifa Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flourescein staining, miboscore	intense pulsed light	-

Primary Outcome Measures

Name	Time	Method
Tear film break up time (TBUT)	6 months	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	6 months	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	6 months	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.

Trial Locations

Locations (1)

Dar alshif hospital; 🇰🇼 Kuwait, Kuwait