XerophthalmiaNCT04636372
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
A study testing Intense pulsed light therapy and Hot compress massage in people with Xerophthalmia, run by Yune Zhao.
Trial summary
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Xerophthalmia
- What is being tested?
- Intense pulsed light therapy and Hot compress massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Jan 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Previously untreated patients with xerophthalmia
Who cannot join
- No history of ocular surgery and trauma
- Any eye diseases except xerophthalmia
- No treated for xerophthalmia before
- Successful completion of follow-ups
About this study
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.
- Conditions
- Xerophthalmia
- Being tested
- Intense pulsed light therapy, Hot compress massage
- Medical subject headings
- Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense pulsed light therapyDevice
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.
Hot compress massageOther
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.
| Study group | Role | What they receive |
|---|---|---|
| Intense pulsed light therapy group | Experimental | Not described Receives: Device: Intense pulsed light therapy |
| Hot compress massage group | Experimental | Not described Receives: Other: Hot compress massage |
| Intense pulsed light therapy and hot compress massage group | Experimental | Not described Receives: Device: Intense pulsed light therapy; Other: Hot compress massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of meibomian glands after the treatment.
Length in millimeters.
Measured: up to 2 months
The area of meibomian glands after the treatment.
Area in millimeters^2.
Measured: up to 2 months
The percentage of meibomian glands after the treatment.
Percentage of meibomian glands in %(area of meibomian glands (mm^2) and area of palpebral conjunctiva (mm^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Why it stopped: An one-month follow-up was completed after the treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerophthalmiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636372
- Sponsor's protocol ID
- LXY-meibomian gland
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
- ClinicalTrials.gov ID
- NCT04636372
- Acronym / sponsor ID
- LXY-meibomian gland
- Conditions
- Xerophthalmia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: An one-month follow-up was completed after the treatment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 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.
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intense pulsed light therapy group | Experimental | Device: Intense pulsed light therapy |
| Hot compress massage group | Experimental | Other: Hot compress massage |
| Intense pulsed light therapy and hot compress massage group | Experimental | Device: Intense pulsed light therapy, Other: Hot compress massage |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Previously untreated patients with xerophthalmia
Key exclusion criteria (4 listed)
- No history of ocular surgery and trauma
- Any eye diseases except xerophthalmia
- No treated for xerophthalmia before
- Successful completion of follow-ups
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 light therapyPatients with xerophthalmia were treated with intense pulsed light of meibomian gland. | Device | Intense pulsed light therapy and hot compress massage group, Intense pulsed light therapy group |
| Hot compress massagePatients with xerophthalmia were treated with hot compress massage of meibomian gland. | Other | Hot compress massage group, Intense pulsed light therapy and hot compress massage group |
Primary outcome
The length of meibomian glands after the treatment.
Time frame: up to 2 months
Length in millimeters.
The area of meibomian glands after the treatment.
Time frame: up to 2 months
Area in millimeters^2.
The percentage of meibomian glands after the treatment.
Time frame: up to 2 months
Percentage of meibomian glands in %(area of meibomian glands (mm^2) and area of palpebral conjunctiva (mm^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intense pulsed light therapy and Hot compress massage in people with Xerophthalmia, run by Yune Zhao.
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 1 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: withdrawn, as of the sponsor's last update on 19 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of meibomian glands after the treatment. (time frame: up to 2 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 19 Nov 2020.