Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

NCT04904874 | Unknown

• 1 other identifier: 02282021065726
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

flourescein staining, miboscore

OTHER

Device: intense pulsed light

Interventions

intense pulsed light DEVICE

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

flourescein staining, miboscore

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• the presence of active skin lesions, skin cancer, or other specific skin pathology.
• active ocular infection or ocular inflammatory disease.

Sponsors & Collaborators

• Dar Al Shifa Hospital: lead

Study Sites (1)

Dar alshif hospital

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Magda Torky

CONTACT

0096594492487; magda_turkey@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: catract and refractie surgery specilaist

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: December 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)