ClinicalTrials.gg
Status unknownNCT04904874Updated May 27, 2021

Intense Pulsed Light Therapy in Meibomian Gland Dysfunction

An interventional study of intense pulsed light in Meibomian Gland Dysfunction, sponsored by Dar Al Shifa Hospital. Status unknown at 1 site in Kuwait. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Dar Al Shifa Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Meibomian Gland Dysfunction
03

In context

Meibomian Gland Dysfunction

172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.

Browse Meibomian Gland Dysfunction studies →

Lead sponsor

Dar Al Shifa Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • the presence of active skin lesions, skin cancer, or other specific skin pathology.
  • active ocular infection or ocular inflammatory disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    flourescein staining, miboscore

    Device: intense pulsed light

Interventions

  • Deviceintense pulsed light

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Dar alshif hospital
    Kuwait, Kuwait
    Recruiting
    • magda torky · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2020 (actual). Primary completion is estimated for Jul 2021, 7 months after the start.

Of 52 non-industry interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 7 months is below that.

Counting every sponsor, half of 74 studies reached it within 11 months; a quarter within 5 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2021
First posted
May 27, 2021
StartActual
Dec 1, 2020
Primary completionEst.
Jul 30, 2021
CompletionEst.
Jul 30, 2021
Last update
May 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904874
Lead sponsor
Dar Al Shifa Hospital
Responsible party
magda torky (catract and refractie surgery specilaist, Dar Al Shifa Hospital) — Principal investigator
First posted
May 27, 2021
Start date
Dec 1, 2020
Primary completion
Jul 30, 2021 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
May 27, 2021

Study contacts

Magda Torky
Contact
magda_turkey@yahoo.com
0096594492487

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion