Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

Sponsor
Dar Al Shifa Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04904874
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
7.9
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: intense pulsed light
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Other: flourescein staining, miboscore

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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Dar alshif hospitalKuwaitKuwait

Sponsors and Collaborators

  • Dar Al Shifa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
magda torky, catract and refractie surgery specilaist, Dar Al Shifa Hospital
ClinicalTrials.gov Identifier:
NCT04904874
Other Study ID Numbers:
  • 02282021065726
First Posted:
May 27, 2021
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2021