Meibomian Gland DysfunctionNCT04633798
Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
A study testing IPL/Lipiflow and IPL/MGX in people with Meibomian Gland Dysfunction, run by Aier School of Ophthalmology, Central South University.
Trial summary
To compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- IPL/Lipiflow and IPL/MGX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 21 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with meibomian gland dysfunction
- patients with ocular discomfort
- skin type:FitzpatricⅠ-Ⅳ
Who cannot join
- patients with acute ocular inflammation
- eye surgery history in the last 12 months
- patients who have received IPL or Lipiflow in the last 12 months
- patients who wear contact lens in last one month
Trial locations and contacts
No sites are listed yet.
About this study
To compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology.
Read the detailed description
To divide all participants into two groups, group one treated with IPL combined with Lipiflow and group two treated with IPL combined with meibomian gland massage.The following parameters were recorded after treatment: the effective rate, lasting time and changes of meibomian gland function and morphology.All parameters were compared between the two groups.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- IPL/Lipiflow, IPL/MGX
- 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.
IPL/LipiflowProcedure or surgery
To treat patients with MGD using intense pulsed light combined with lipiflow
IPL/MGXProcedure or surgery
To treat patients with MGD using intense pulsed light combined with meibomian gland massage
| Study group | Role | What they receive |
|---|---|---|
| IPL/Lipiflow | Experimental | the group in which patients treated with IPL combined with lipiflow Receives: Procedure: IPL/Lipiflow |
| IPL/MGX | Active comparator | the group in which patients treated with IPL combined with meibomian gland massage Receives: Procedure: IPL/MGX |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular surface disease index(OSDI)
The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability
Measured: 6 months
meibomian gland expressibility score and meibum quality score
The score is on a scale of 0 to 6.The higher scores, the severity of the meibomian gland function(the highest score is 6 and the lowest score is 0)
Measured: 6 months
meibomian gland dropout score
the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)
Measured: 6 months
Breakup time
the shorter time, the poorer of the tear film stability
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 posted18 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion21 Dec 2020 (estimated)
- Study completion21 Dec 2020 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, doctor, Principal investigator, Shanghai aier eys hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633798
- Sponsor's protocol ID
- SHAIER2020IRB04
- Status last verified
- Nov 2020
- First submitted
- 20 May 2020
- Last updated
- 18 Nov 2020
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04633798
- Acronym / sponsor ID
- SHAIER2020IRB04
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 21 Dec 2020 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 18 Nov 2020 (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 compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology.
Detailed description
To divide all participants into two groups, group one treated with IPL combined with Lipiflow and group two treated with IPL combined with meibomian gland massage.The following parameters were recorded after treatment: the effective rate, lasting time and changes of meibomian gland function and morphology.All parameters were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL/Lipiflow | Experimental | Procedure: IPL/Lipiflowthe group in which patients treated with IPL combined with lipiflow |
| IPL/MGX | Active comparator | Procedure: IPL/MGXthe group in which patients treated with IPL combined with meibomian gland massage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with meibomian gland dysfunction
- patients with ocular discomfort
- skin type:FitzpatricⅠ-Ⅳ
Key exclusion criteria (4 listed)
- patients with acute ocular inflammation
- eye surgery history in the last 12 months
- patients who have received IPL or Lipiflow in the last 12 months
- patients who wear contact lens in last one month
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 |
|---|---|---|
| IPL/LipiflowTo treat patients with MGD using intense pulsed light combined with lipiflow | Procedure or surgery | IPL/Lipiflow |
| IPL/MGXTo treat patients with MGD using intense pulsed light combined with meibomian gland massage | Procedure or surgery | IPL/MGX |
Primary outcome
ocular surface disease index(OSDI)
Time frame: 6 months
The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability
meibomian gland expressibility score and meibum quality score
Time frame: 6 months
The score is on a scale of 0 to 6.The higher scores, the severity of the meibomian gland function(the highest score is 6 and the lowest score is 0)
meibomian gland dropout score
Time frame: 6 months
the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)
Breakup time
Time frame: 6 months
the shorter time, the poorer of the tear film stability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- 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.
Yan Chen, doctor principal investigator
Shanghai aier eys hospital
Questions about this trial
What is this clinical trial studying?
A study testing IPL/Lipiflow and IPL/MGX in people with Meibomian Gland Dysfunction, run by Aier School of Ophthalmology, Central South University.
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 4 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Chen, doctor (+86-021-62956699, chinacy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular surface disease index(OSDI) (time frame: 6 months). The study lists 4 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 18 Nov 2020.