Meibomian Gland DysfunctionNCT04904874
Intense Pulsed Light Therapy in Meibomian Gland Dysfunction
A study testing intense pulsed light in people with Meibomian Gland Dysfunction, run by Dar Al Shifa Hospital at 1 site in Kuwait.
Trial summary
to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- intense pulsed light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Dec 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- the presence of active skin lesions, skin cancer, or other specific skin pathology.
- active ocular infection or ocular inflammatory disease.
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dar alshif hospital
Kuwait City
magda torky
About this study
Official title: Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- intense pulsed light
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intense pulsed lightDevice
treatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| flourescein staining, miboscore | Other | Not described Receives: Device: intense pulsed light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Dec 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, magda torky, Dar Al Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904874
- Sponsor's protocol ID
- 02282021065726
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04904874
- Acronym / sponsor ID
- 02282021065726
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dar Al Shifa HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flourescein staining, miboscore | Other | Device: intense pulsed light |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- the presence of active skin lesions, skin cancer, or other specific skin pathology.
- active ocular infection or ocular inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intense pulsed lighttreatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks | Device | flourescein staining, miboscore |
Primary outcome
Tear film break up time (TBUT)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intense pulsed light in people with Meibomian Gland Dysfunction, run by Dar Al Shifa Hospital at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Torky (0096594492487, magda_turkey@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film break up time (TBUT) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.